louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06247332: SENSING-AI in Patients With Long COVID (SENSING-AI)
Official title: Retrospective Data Collection for SENSING-AI: a Wearable Platform for the Early Diagnosis of Emotional Disorders and Exacerbations in Patients With Long COVID Through the Use of Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-acute COVID-19 Syndrome
Keywords: Long COVID-19
Retrospective study
Artificial Intelligence
Mental Health
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Virgen Macarena
First posted: 2024-02-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size for the retrospective study enough to generate a first version of the risk stratification models will be around 100 cases. The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care.

Brief summary: The retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better managing the healthcare process for patients diagnosed with long COVID.

Detailed description: The stratification of the risk of complications related to persistent COVID both physiological and psychological in a personalized way would optimize the cost-effectiveness model for the management of these patients. Similarly, the early detection of complications associated with persistent COVID in patients belonging to vulnerable groups would improve care times and, therefore, the patient's prognosis.

The primary objective for this study is to gather anonymized retrospective data of patients suffering from long COVID in order to contribute to the generation of the SENSING-AI cohort.

Eligibility criteria: Inclusion Criteria:

* Legal adult
* Diagnosed of long COVID-19 in the last year
* With the presence of any of these symptoms:
* Asthenia (Tiredness)
* Dyspnea
* Shortness of breath
* Anxiety
* Stress
* Depression
* Sleep disorder

Exclusion Criteria:

* Attended to specialized care consultation
* Was admitted in hospital in the last year due to a problem not related to the COVID complications

Primary outcomes:
measure: Retrospective SENSING-AI cohort
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Virgen Macarena University Hospital
Study officials:
References:
Clinical trial NCT04628832: Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
Official title: Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: opioids
prescribing
benzodiazepines
gabapentinoids
clinical guidelines
overprescribing
Benzodiazepine Use
Gabapentin Use
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Minnesota Management and Budget Agency
name: Minnesota Board of Pharmacy
First posted: 2020-11-16
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.


Eligibility criteria: Inclusion Criteria:

* Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids

Exclusion Criteria:

* Specialization in oncology or palliative medicine

Primary outcomes:
measure: Count of Patients with Co-Prescriptions
timeFrame: 60 days
measure: Rate of Prescribers Checking PMP
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota Board of Pharmacy
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Management and Budget Agency
state: Minnesota
Study officials:
affiliation: Columbia University
name: Adam Sacarny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Mireille Jacobson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: David Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309632: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Official title: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Neoplasms
Peutz-Jegher's Syndrome
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ataxia Telangiectasia
Familial Atypical Mole-Malignant Melanoma Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Pancreatitis
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.


Eligibility criteria: Inclusion Criteria:

* Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
* Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
* Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
* Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
* Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
* Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
* Patients with a known PALB2 mutation with one affected family member should be considered for screening.
* Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.

Exclusion Criteria:

* Not candidates for surgery

Primary outcomes:
measure: Detection rate of PC and precancerous lesion
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Kent D McKelvey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04410432: Immune Response and Risk of Serious Infection to SARS-Cov2
Official title: Immune Response and Risk of Serious Infection to SARS-Cov2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS Cov2, Immune Response
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 63
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 hospitalized for SARS-Cov-2 infection

Brief summary: To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.


Eligibility criteria: Inclusion Criteria:

* Person having given his or her non-opposition
* Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a safeguard measure of justice
* Pregnant, parturient or breastfeeding woman
* Major incapable or incapable of giving consent
* Minor

Primary outcomes:
measure: Percentage of circulating Th1 lymphocytes
timeFrame: Until the end of the study, about 12 months.
Secondary outcomes:
measure: Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11
timeFrame: Until the end of the study, about 12 months.
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT04496232: Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Official title: Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Sperm DNA fragmentation
Second ejaculate
Sperm Selection
PICSI
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

Detailed description: Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

Eligibility criteria: Inclusion Criteria:

* Male partner with abnormal sperm DNA fragmentation index (\>20%) by TUNEL assay
* Male partner with at least 1 million progressive motile count
* Male aged 18-50 years
* Male with adjusted sexual abstinence days (1-2 days)
* Female aged 18-37 years
* Normo-responder females (at least 5 mature oocytes)

Exclusion Criteria:

* Leukocytospermia
* Varicocele
* Known genetic abnormality
* Use of oocyte or sperm donors
* Use of a gestational carrier
* Presence of any endometrial factors that can affect embryo implantation
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Primary outcomes:
measure: Fertilization rate
timeFrame: 16-19 hours
measure: Cleavage rate
timeFrame: 3 days
measure: Blastulation rate
timeFrame: 5-6 days
measure: Blastocyst quality rate
timeFrame: 5-6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: القاهرة
Study officials:
affiliation: Ganin Fertility Center
name: Eman Hasanen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Radwa Omar
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Alkhader
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_DIRECTOR
affiliation: Ganin Fertility Center
name: Manar Hozayen, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02970032: Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
Official title: Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deep-Venous Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500 units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for venous thromboembolism (VTE) prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 500 units/hour.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgical procedures
* Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

Exclusion Criteria:

* Age \<18 years old
* Pregnant
* Incarcerated
* Mentally disabled

Primary outcomes:
measure: Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Number of Rate Adjustments
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Univeristy of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah Health
name: Corinne Bertolaccini, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708732: Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL)
Official title: UK Utility Study in Diffuse Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 100 patients in first remission with DLBCL will be recruited from online advertisements and a specialist medical recruitment agency to complete study-administered questionnaires.

Brief summary: This study is a prospective, cross-sectional survey to be administered to real patients in remission from DLBCL using a 15-minute postal or online survey. The project is designed to describe the impact of DLBCL remission on health utility and quality of life. Data collection will occur over a 4-month period.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (\>/=) 18 years of age
* Diagnosis of DLBCL and currently in first remission
* Prior drug treatment for DLBCL

Exclusion Criteria:

* Receiving active treatment for DLBCL
* Relapsed following any treatment for DLBCL

Primary outcomes:
measure: Health-Related Quality of Life According to European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Score
timeFrame: Up to 4 months of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Marlow
country: United Kingdom
facility: PH Associates - an OPen Health Company
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05390632: Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas
Official title: Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PET/MRI
Keywords: Positron-Emission Tomography
lymphoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
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 pathologically diagnosed as lymphoma

Brief summary: Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas

Detailed description: In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by 18F-FDG PET (PET/CT and PET/MR). Prior to treatment, all patients will undergo whole-body 18F-FDG PET/CT and PET/MR. The methods' efficiency was compared in the diagnosis of lymph node (LN) and organ involvement.

Eligibility criteria: Inclusion Criteria:

* pathologically diagnosed as lymphoma; Written informed consent for receiving PET/MRI after PET/CT examinations. cancer planned chemotherapy or immunotherapy scheme. expected survival ≥ 12 weeks

Exclusion Criteria:

* cannot lie supine for half an hour; refuse to join the clinical researcher; severe liver or kidney dysfunction pregnancy or lactation

Primary outcomes:
measure: SUVmax
timeFrame: 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Card Holder's Billing State / Province
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhi Yang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02275832: Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement
Official title: Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Beard Enhancement
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 48
Sex: MALE
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 determine efficacy and safety of 3% minoxidil lotion for beard enhancement.


Eligibility criteria: Inclusion Criteria:

* Healthy male

Exclusion Criteria:

* serious underlying diseases.
* history of beard/ hair treatment before 6 months
* history of surgery or trauma on beard area.
* history of minoxidil allergy

Primary outcomes:
measure: The change of global photographic assessment after 16 weeks from baseline
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: The change in number of hairs after 16 weeks from baseline
timeFrame: baseline and 16 weeks
Other outcomes:
measure: The change of hair diameter after 16 weeks from baseline
timeFrame: baseline and 16 weeks
measure: Number of participants with adverse events
timeFrame: baseline and 16 weeks
measure: Patient satisfaction by self-assessment questionnaires
timeFrame: baseline and 16 weeks
Locations:
city: Bangkok
country: Thailand
facility: MFL University Hospital (Bangkok)
Study officials:
affiliation: MFL University Hospital (Bangkok)
name: Chuchai Tanglertsampan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Tanglertsampan C, Tanchotikul M, Worapunpong N. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study. J Dermatol. 2014 Feb;41(2):149-52. doi: 10.1111/1346-8138.12275. Epub 2013 Nov 8.
citation: Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.
citation: Tanglertsampan C. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study. J Med Assoc Thai. 2012 Oct;95(10):1312-6.