louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00951925: Protocol to Obtain Bone Marrow for Research
Official title: Protocol to Obtain Bone Marrow for Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Biopsy
Keywords: diagnostic bone marrow biopsies
bone marrow harvesting for autologous BMT
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of Dartmouth Hitchcock Medical Center (DHMC).
* Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.

Brief summary: Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of clinical care will be asked by the principal investigator (PI) if they might be interested in donating marrow for this research project. If they are interested, the PI will meet with the prospective donor to review the information contained in the informed consent document and to answer any questions the potential subject may have. Bone marrow aspirates of approximately 5cc will be obtained from the posterior iliac crest of subjects using standard techniques.

Detailed description: The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases. This includes the effects of drugs and other in vitro manipulations of the cells once they are removed from donors. These assays will include, but are not limited to, determinations of DNA methylation status, histone acetylation profiles, DNAse sensitivity, transcription factor binding to DNA, levels of various proteins, messenger RNAs and miRNAs in the cells of the marrow samples. By understanding how this process occurs in people without blood diseases, we hope to to design future treatments for people with diseases such as sickle cell disease and B-thalassemia.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of DHMC.
* Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.
* Normal donors undergoing bone marrow harvesting for autologous bone marrow transplantation.
* Normal persons over the age of 17 who volunteer to undergo bone marrow aspiration.

Exclusion Criteria:

* Normal volunteers with known allergies to lidocaine (or similar analgesics)or betadine.

Primary outcomes:
measure: Regulation of human globin gene expression
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Christopher H Lowrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435225: Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
Official title: Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder, NOS
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 14
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.


Eligibility criteria: Inclusion Criteria:

* Ages 13-17
* Diagnosed with BD-NOS
* First or second degree relative diagnosed with bipolar I or II

Exclusion Criteria:

* Not English speaking
* For those who are to participate in the MRI scan, having any metal in the body or movement disorders will be an exclusionary factor

Primary outcomes:
measure: Dorsal Medial Network functional connectivity
timeFrame: 12 weeks
measure: Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
timeFrame: 12 weeks
Secondary outcomes:
measure: Degree of Mindfulness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kiki D Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02753725: Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)
Official title: Effect of Fentanyl Given Approximately Ten Minutes to the End of Surgery on Emergence Delirium in Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital: A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Delirium
Lead sponsor: University of Nairobi
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.


Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists classes (ASA) 1 and 2 children.

  * ASA 1 - Normal healthy child scheduled for adeno-tonsilectomy.
  * ASA 2 - Child with mild systemic disease without functional limitations.
* Children aged 1 to 12 years.
* Children undergoing elective adeno-tonsilectomy.
* Those children whose parents/guardians have given a written informed consent.

Exclusion Criteria:

* Children with genetic syndromes.
* Children with psychological/neurological behavioural disorders.
* Children with allergies to Fentanyl.
* Children with psychiatric disorders/ use of psychiatric medications.
* Use of sedative medications one hour prior to surgery.
* Children with developmental delay.
* Children coming in as day case.
* Children with airway problems not related to the surgery-sleep apnoea.
* Children less than 1 year and those above 13 years.

Primary outcomes:
measure: The number of patients who develop emergence delirium in both arms
timeFrame: 30 minutes
measure: the local incidence of emergence delirium.
timeFrame: 30 minutes
Secondary outcomes:
measure: the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.
timeFrame: 30 minutes
measure: duration of emergence time from general anaesthesia in minutes
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03148925: Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: nicotine vaccine
smoking vaccine
smoking cessation
SELA-070
Lead sponsor: Selecta Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.


Eligibility criteria: Primary Inclusion Criteria:

* Healthy Smokers
* Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment
* Written informed consent

Primary Exclusion Criteria:

* Prior exposure to nicotine vaccines
* Female subjects of childbearing potential
* Current use of immunosuppressive agents
* History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.

Primary outcomes:
measure: Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity
timeFrame: 21 weeks
Secondary outcomes:
measure: Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).
timeFrame: 21 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit
Study officials:
affiliation: SGS LSS Clinical Pharmacology Unit - Antwerpen
name: Alexander Lucardie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087125: Abatacept Pregnancy Exposure Registry
Official title: Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
name: The Organization of Teratology Information Specialists
First posted: 2010-03-16
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants

Exclusion Criteria:

* Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality

Primary outcomes:
measure: Major structural birth defects of newborns
timeFrame: Throughout pregnancy and up to 1 year of life
Secondary outcomes:
measure: 3 or more minor structural defects
timeFrame: at dysmorphological exam
measure: Spontaneous abortion
timeFrame: throughout pregnancy
measure: Premature delivery
timeFrame: throughout pregnancy
measure: Small for gestational age
timeFrame: at birth
measure: Postnatal growth deficiency
timeFrame: throughout pregnancy and up to 1 year of life
measure: Postnatal serious infections, hospitalizations or malignancies
timeFrame: 1st year of life
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol-Myers Squibb, Active
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00300625: Validation of the San Francisco Syncope Rule
Official title: Validation of the San Francisco Syncope Rule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Near Syncope
Keywords: Syncope
Near syncope
San Francisco Syncope rule
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2006-03-09
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope (passed out) or near syncope (almost passed out). A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event and require admission.

Detailed description: This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope or near syncope.

A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event/serious outcome and require admission. Serious outcomes include the following: death,myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.

In Quinn's derivation trial, the sensitivity of the rule was 96%.

Eligibility criteria: Inclusion Criteria: Acute syncope or near syncope as a reason for the ED visit

Exclusion Criteria: Altered mental status, alcohol or illicit drug-related loss of consciousness, Definite seizure, Transient loss of consciousness caused by head trauma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Adrienne J Birnbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: E J Gallagher, MD
role: STUDY_CHAIR
References:
citation: Quinn JV, Stiell IG, McDermott DA, Kohn MA, Wells GA. The San Francisco Syncope Rule vs physician judgment and decision making. Am J Emerg Med. 2005 Oct;23(6):782-6. doi: 10.1016/j.ajem.2004.11.009.
Clinical trial NCT04222725: A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
Official title: A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post Surgical Ocular Inflammation
Keywords: postoperative
postsurgical
ocular
inflammation
pain
Lead sponsor: Tarsier Pharma
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.


Eligibility criteria: Inclusion Criteria:

Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:

* 18 years of age or older.
* Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
* Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
* Have vision ≥ 20/200 in the non-study eye.
* Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
* Have no known sensitivity /allergy to the TRS01 or formulation excipients.
* Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
* Randomization inclusion criteria as specified per protocol.

Exclusion Criteria:

* Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
* Receiving specific medication/interventions as specified per protocol

Primary outcomes:
measure: Assessment of Both Systemic and Ocular Adverse Events
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Inglewood
state: California
city: Petaluma
country: United States
facility: Petaluma
state: California
city: Washington
country: United States
facility: Washington, MO
state: Missouri
city: New York
country: United States
facility: New York
state: New York
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
Study officials:
References:
Clinical trial NCT05217225: The Association Between Parental Anxiety and Child Behavior.
Official title: The Association Between Parental Anxiety and Child Behavior During Simple Restorative Treatment: A Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parental Anxiety,Child Behavior
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 158
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and parents attending to diagnosis clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.

Brief summary: Parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development.

Studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries disease in their children, since they are more resistant to accompany their children to the dentist.

People with a high level of dental anxiety, both children and adults, can be difficult to treat, take longer, and have behavioral issues, all of which can lead to a stressful and unpleasant experience for both the patient and the dental practitioner


Eligibility criteria: Inclusion Criteria:

* Children, age ranging from 4 to 6 years old, of both sexes, have simple Occlusal cavities attending the pediatric dental clinic.
* Parents of both genders

Exclusion Criteria:

* Children who do not have the cognition to respond to the anxiety test or are not authorized by parents and medically compromised children.
* Parents who could not respond to the research tools.

Primary outcomes:
measure: Prevalence of Parental anxiety
timeFrame: baseline
Secondary outcomes:
measure: Prevalence of Child Anxiety
timeFrame: Baseline
measure: Child behavior in dental care
timeFrame: During the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01504425: Difficult Colon Polypectomies
Official title: An Observational Study of Difficult Colonic Polypectomies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with colonic polyps that are deemed difficult to resect

Brief summary: The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.


Eligibility criteria: Inclusion Criteria:

* colonic polyps that are deemed difficult to resect by the endoscopist

Exclusion Criteria:

* patient refusal to participate in the trial

Primary outcomes:
measure: complication rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Hospital
Study officials:
affiliation: Clinical Hospital Colentina
name: Theodor Voiosu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voiosu T, Ratiu I, Hervoso CM, Furnari M, Voiosu A, Goldis A, Mateescu B, Tacconi M, Dulbecco P, Haidar A, Voiosu MR, Sporea I. Polyp and endoscopist-related factors influencing complication rates in difficult colonic polypectomies: results of a multicenter observational study. Rom J Intern Med. 2013 Jul-Dec;51(3-4):172-8.