louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01183338: Accuracy of Continuous SpO2 Measurement in Adults
Official title: SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: SpO2
Oxygen saturation
Lead sponsor: Sotera Wireless, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult volunteers, male or female, of any ethnic background. To the extent possible while still achieving timely enrollment, subjects should vary from one another in their physical characteristics. Each subject must also meet all of the inclusion and exclusion criteria prior to study entry and give informed consent to participate in this study.

Brief summary: The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

Detailed description: This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.

SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
* Subject is willing and able to participate in the measurement period for up to two hours.

Exclusion Criteria:

* Subject has a carboxyhemoglobin level (COHb) ≥3%.
* Subject has a MetHb level ≥2%.
* Subject has a ctHb value ≤10g/dl.
* Subject is in another clinical study that may interfere with the results of this study.
* Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
* Subject is deemed by the Investigator to be medically unsuitable for participation in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark Desaturation Laboratory
state: Colorado
Study officials:
affiliation: VA Medical Center
name: Philip S. Clifford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02302638: Embryo Development Using Two Commercial Single-step Media
Official title: Embryo Development and Utilization Using Two Commercial Single-step Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: single-step media
embryo development
blastocyst formation
embryo utilization
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.


Eligibility criteria: Inclusion Criteria:

* at least 10 oocytes retrieved

Exclusion Criteria:

* frozen oocytes
* testicular biopsy
* less than 10 oocytes retrieved
* older than 40 years

Primary outcomes:
measure: Utilization rates
timeFrame: 6 days post oocyte retrieval
measure: Blastocyst formation
timeFrame: 5 days post oocyte retrieval
Secondary outcomes:
measure: Embryo quality on day 3
timeFrame: 3 days post oocyte retrieval
measure: blastocyst quality on day 5
timeFrame: 5 days post oocyte retrieval
measure: positive pregnancy test
timeFrame: 15 days post oocyte retrieval
measure: clinical pregnancy
timeFrame: 7 weeks of gestation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Assisted Reproduction Unit
state: Attica
Study officials:
affiliation: Eugonia
name: Ioannis A Sfontouris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sfontouris IA, Kolibianakis EM, Lainas GT, Venetis CA, Petsas GK, Tarlatzis BC, Lainas TG. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes. J Assist Reprod Genet. 2017 Oct;34(10):1377-1383. doi: 10.1007/s10815-017-0997-0. Epub 2017 Jul 17.
Clinical trial NCT05994638: Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Official title: Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Mucositis
Keywords: Radiotherapy
Head and neck cancer
Dysphagia
Oral Mucositis
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.

Detailed description: The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.

Eligibility criteria: Inclusion Criteria:

* Women and men, 18-75 years old
* Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis
* Patients with dryness in mouth
* Signed informed consent.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins
* Participation in another clinical trial,
* Women who are pregnant, planning to become pregnant during the study or breastfeeding,
* Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.
* Hypersensitivity/allergy to any of the ingredient

Primary outcomes:
measure: Side effects after radiotherapy
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Impact of dysphagia on quality of life
timeFrame: Baseline, 1 month
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Stomatologiczne GUMed
Study officials:
References:
Clinical trial NCT06717438: Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Study of Zatolmilast (BPN14770) in Subjects With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Jordan's Syndrome
PPP2R5D Neurodevelopmental Disorder
Keywords: Jordan's Syndrome
JS
PPP2R5D Neurodevelopmental Disorder
Zatolmilast
BPN14770
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and tolerability of BPN14770 in participants aged 9 to 45 years with JS.


Eligibility criteria: Inclusion Criteria:

1. Participant is aged 9 to 45 years, inclusive.
2. Participant has confirmed/documented history of PPP2R5D Neurodevelopmental Disorder.
3. Current treatment with no more than 3 prescribed psychotropic medications.
4. Participant has a parent, legal authorized guardian or consistent caregiver.

Exclusion Criteria:

1. Participant has body weight less than 25 kilograms (kg).
2. Clinically significant abnormalities, in the investigator's judgment, in safety laboratory tests, vital signs, or electrocardiogram (ECG), as measured during Screening.
3. Concurrent major psychiatric condition (e.g., Major Depressive Disorder, Schizophrenia or Bipolar Disorder) as diagnosed by the investigator. Participants with additional diagnosis of Autism Spectrum Disorder or Anxiety Disorder will be allowed.
4. Participant is planning to commence psychotherapy or cognitive behavior therapy (CBT) during the period of the study or had begun psychotherapy or CBT within 4 weeks prior to Screening.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Week 50
measure: Discontinuation-emergent Signs and Symptoms (DESS) Questionnaire Score
timeFrame: Week 50
measure: Number of Participants with Seizures
timeFrame: Up to Week 50
measure: Number of Participants at Suicidality Risk
timeFrame: Up to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT04342338: Pharmacist and Family Medicine Physician Collaboration for Pre-Visit Planning and Team Huddles for CCM Patients
Official title: Pharmacist and Family Medicine Physician Collaboration for Pre-Visit Planning and Team Huddles for Patients Receiving Chronic Care Management Services
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Conditions, Multiple
Lead sponsor: Northeast Iowa Medical Education Foundation
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medicare patient's who are enrolled in the CCM program at the Northeast Iowa Family Practice Center with Greenwood Pharmacy as their primary pharmacy.

Brief summary: This is a novel project which incorporates clinic and community pharmacists in three aspects of the Patient-Centered Medical Home: pre-visit planning, pre-visit care team huddles, and chronic care management (CCM). Patients for the project are enrolled in the NEIFPC CCM program and have Greenwood pharmacy as their primary pharmacy. Community and clinic pharmacists will contribute to pre-visit medication reviews and document their drug therapy recommendations in a shared, templated note in the clinic EHR. NEIFPC pharmacists will attend pre-visit team huddles to relay drug therapy recommendations to the physician. Revenue from CCM services will be prorated and shared between Greenwood pharmacy and NEIFPC. The project will last 9 months. Primary aims are to describe the pharmacist pre-visit planning service, summarize the billing experience of a community pharmacist providing this service, and to describe the drug therapy interventions made by pharmacists.


Eligibility criteria: Inclusion Criteria:

* Patient enrolled in Medicare
* Patient enrolled in the Chronic Care Management (CCM) program at the Northeast Iowa Family Practice Center
* Patient's primary pharmacy is Greenwood Pharmacy

Exclusion Criteria:

* Patient not enrolled in Medicare
* Patient not enrolled in CCM program
* Patient's primary pharmacy is any pharmacy other than Greenwood Pharmacy

Primary outcomes:
measure: Summary of Drug Therapy Interventions made by Pharmacists
timeFrame: 07/01/2020- 03/31/2021
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: United States
facility: Northeast Iowa Family Practice
state: Iowa
Study officials:
References:
Clinical trial NCT03600038: Smoking Cessation Smartphone App for Cancer Patients (Quit2Heal Study)
Official title: Pilot Trial of a Smartphone Smoking Cessation Application Intervention for Cancer Patients (Quit2Heal Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Smoking
Keywords: Smoking cessation
App for quitting smoking
Cancer
Oncology
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: CVS Health Foundation
First posted: 2018-07-26
Enrollment: 59
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 goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app.

Detailed description: Cigarette smoking has harmful effects on cancer patients' treatment and prognosis, but there are systemic barriers to delivering smoking cessation interventions to cancer patients. One solution for addressing these barriers is to give patients immediate access to smoking cessation treatment via a smartphone application. The Quit2Heal smartphone app is engaging and tailored to the specific needs of cancer patients, and can be integrated into routine cancer care. The goal of this study is to determine whether Quit2Heal provides higher quit rates than the current standard smoking cessation app.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* diagnosed with cancer in the past 12 months
* has smoked a cigarette (even a puff) in the past 30 days
* interested in learning skills to quit smoking
* willing to be randomly assigned to either smartphone application
* resides in US
* has at least daily access to their own smartphone
* knows how to login and download a smartphone application from the Apple app store or Android Play app store
* willing and able to read in English
* not currently using cessation medications or enrolled in other smoking cessation programs, and
* has never used the NCI's Quit Guide smartphone application.
* willing and able to complete one follow-up survey
* willing to provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are opposite of the inclusion criteria listed above.

Primary outcomes:
measure: 30-day point prevalence abstinence
timeFrame: 2 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Bricker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bricker JB, Watson NL, Heffner JL, Sullivan B, Mull K, Kwon D, Westmaas JL, Ostroff J. A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness. JMIR Form Res. 2020 Jan 17;4(1):e16652. doi: 10.2196/16652.
Clinical trial NCT01093638: Oral Formulation of Insulin for Preterm Infants
Official title: A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Premature Birth of Newborn
Lead sponsor: Elgan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 33
Sex: ALL
Minimum age (years): 26
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

Detailed description: The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.

Eligibility criteria: Inclusion Criteria:

1. Pre-term infants 26-33 weeks gestation.

Primary outcomes:
measure: Number of days to achieve complete enteral feeding
timeFrame: Up to 28 days or discharge and at 3 months of age
Secondary outcomes:
measure: Number of gastric residual > 2 ml/kg
timeFrame: Up to 28 days or discharge, at 3 months of age
measure: Number of gastric residual > 50% of previous feeding
timeFrame: Up to 28 days or discharge and at 3 months of age
measure: Number of days to discharge
timeFrame: Up to 28 days or discharge and at 3 months of age
measure: Weight gain
timeFrame: Up to 28 days or discharge and at 3 months of age
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: NICU, Laniado Hospital
Study officials:
affiliation: Rambam Health Care Campus
name: Naim Shehadeh, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04421638: Cephalosporin Hypersensitivity
Official title: Drug Hypersensitivity Reactions To Cephalosporins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Keywords: Drug Hypersensitivity Reaction
Drug Provocation Test
Cephalosporins
Betalactams
Risk Factor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient consulting in our allergy unit for a suspicion of DHR to cephalosporins and who underwent a drug allergy work-up.

Brief summary: Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).


Eligibility criteria: Inclusion criteria:

- Patients with one or more ST and DPT tests to cephalosporins

Exclusion criteria:

- Patients refusing to take part in the study

Primary outcomes:
measure: Identify clinical variables associated with allergy to cephalosporins
timeFrame: 1 day
Secondary outcomes:
measure: Determine the risk variables associated with allergy to cephalosporins
timeFrame: 1 day
measure: To calculate the negative predictive value of cephalosporin DTP
timeFrame: 1 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Anca Chiriac, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780738: A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
Official title: A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: Aortic dissection
Aldehyde dehydrogenase 2 polymorphism
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with aortic dissection in Guangdong Provincial People's Hospital

Brief summary: The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.


Eligibility criteria: Inclusion Criteria:

* Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital

Exclusion Criteria:

* Aortic dissection based on trauma, connective tissue diseases and pregnancy
* Patients with tumor
* Patients with no written consensus

Primary outcomes:
measure: Number of patients with different ALDH2 genotype
timeFrame: 1-30 days after samples collected
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: