louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03938961: Metabolic and Nutritional Characteristics of Long-stayer ICU Patients
Official title: Long-stayer Critically Ill Patients: is the Metabolic and Nutritional Therapy in the ICU Creating the Problem?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Metabolism, Energy,Glucose, Protein, Energy deficit
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 205
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: Critically ill patients who required more than 2 weeks of ICU treatment, and who have entered the ICU's long stayer program

Brief summary: The intensive care (ICU) patient population has increasing number of very long ICU stays. Long-stayers are usually defined as requiring more than 1 week of mechanical ventilation and of ICU therapy: little is know about their metabolic characteristics and their relation to outcome. The study aims at describing the demographic, nutritional and metabolic aspects of their stay.

Analysis of 200-250 consecutive patients admitted to the ICU long-stayer program.

Detailed description: Data extracted from the computerized ICU system (PDMS): age, Simplified acute physiology score (SAPSII), weight, BMI, Nutrition Risk Score (NRS-2002), daily energy, protein, and glucose intakes, Energy balance, blood glucose (dysglycemia and Glu variability) and lactate, 24hr-insulin (Goal Glu 6-8 mmol/l).

Outcome variables: length of stay (LICU), muscle strength (MRC), vital status at 90 days.

Patients will be followed in detail until ICU discharge and for vital status until day 90 after admission Data will be presented as mean or median, univariate and multivariate analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* ICU length of stay \> 7 days and enrollment to the long-stayer ICU program

Exclusion Criteria:

* Major burns
* Brain injury
* Severe neurological condition as primary disease

Primary outcomes:
measure: Vital Status
timeFrame: up to 90 days
Secondary outcomes:
measure: Force
timeFrame: up to 90 days
Other outcomes:
measure: Decubitus ulcer
timeFrame: up to 90 days
Locations:
city: Lausanne
country: Switzerland
facility: Adult ICU and Burns, University of Lausanne Hospital
state: Vaud
Study officials:
References:
citation: Loss SH, Nunes DSL, Franzosi OS, Salazar GS, Teixeira C, Vieira SRR. Chronic critical illness: are we saving patients or creating victims? Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):87-95. doi: 10.5935/0103-507X.20170013.
citation: Viana MV, Pantet O, Bagnoud G, Martinez A, Favre E, Charriere M, Favre D, Eckert P, Berger MM. Metabolic and Nutritional Characteristics of Long-Stay Critically Ill Patients. J Clin Med. 2019 Jul 7;8(7):985. doi: 10.3390/jcm8070985.
Clinical trial NCT00271661: Presbyopia in Breast Cancer Survivors
Official title: Presbyopia in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Presbyopia
Keywords: presbyopia; breast cancer survivors
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%.

The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Detailed description: Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process called accommodation. It is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. Currently, there are no known treatments that can be used to prevent or delay presbyopia. As a result, the risk, in later life, of having this condition is essentially 100%.

The purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. We hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Eligibility criteria: Inclusion Criteria:

* ages 45-60
* ability to understand and provide written consent in English

Exclusion Criteria:

* blindness
* visual defects leading to accommodative failure
* severe myopia
* recurrent breast cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AHS Cancer Control Alberta
name: John Mackey, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991261: Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
Official title: A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects


Eligibility criteria: Inclusion Criteria:

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at Screening
3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
4. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.

Exclusion Criteria:

1. Females who are pregnant, lactating, or likely to become pregnant during the study
2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
3. Subjects who need to maintain mental alertness throughout the study
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results

Primary outcomes:
measure: AUC
timeFrame: 48 hours
measure: Cmax
timeFrame: 48 hours
Secondary outcomes:
measure: Adverse event
timeFrame: 25 days
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: SPARC Site 01
state: New Jersey
Study officials:
References:
Clinical trial NCT04393961: At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Official title: At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID19
COVID-19
Coronavirus
Keywords: antibody
testing
remote trial
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Radish Health
name: Sanesco
First posted: 2020-05-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will include four arms. The experiences across all 4 arms will be exactly the same. Each arm has a slightly different experience with COVID-19.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.


Eligibility criteria: Inclusion Criteria:

* Reside and Currently in New York City
* Does not have a blood clotting disease
* Is not abnormally queasy about taking a blood sample
* Not on any blood thinning medications
* Able to consent
* Willingness to take a blood sample
* Confirmed of highly likely past infection with COVID-19 over 14 days ago and fully recovered

Primary outcomes:
measure: Does Participant Accurately Read Result
timeFrame: Day 0
measure: Acceptability and Usability of Tests
timeFrame: Day 0
Secondary outcomes:
measure: Social Distancing Behavior Change
timeFrame: Week 8
measure: COVID-19 Related Anxiety
timeFrame: Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot Online App (https://p.proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT01773161: Cerebral Palsy Hip Health Related Quality of Life
Official title: Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Patient Undergoing Hip Surgery
Quality of Life
Keywords: Cerebral Palsy
Hip surgery
Quality of Life
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital

Brief summary: Children with cerebral palsy are at an increased risk of having their hips move partially or completely out of joint. This can cause pain and restrict movement at the hip, making sitting in a wheelchair uncomfortable and make personal care difficult. This condition may be treated with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or not the surgery has been successful. However, it is also important to know whether the surgery has improved life from the child or the caregiver's point of view. The investigators will also evaluate if waiting for surgery affects the child. This information will be added to results from a physical exam and an evaluation of the child's x-rays for a more complete picture of how this surgery impacts the lives of our patients. It is predicted that that the health-related quality of life of children with cerebral palsy will improve following surgery.

Detailed description: HRQoL will be measured using the Child Health Index of Life with Disabilities (CPCHILD). Our specific hypothesis is that health related quality of life, as measured by the CPCHILD will change by at least a mean of 10 points from pre- to post-surgery.

Eligibility criteria: Inclusion Criteria:

* Ages 4-18
* Undergoing surgical treatment for hip subluxation or dislocation
* Diagnosis of cerebral palsy or similar condition causing motor impairment
* Consent to participate

Exclusion Criteria:

* Diagnosis of neuromuscular disorders other than cerebral palsy
* younger than 4, older than 18
* Reimer's migration percentage \<40%

Primary outcomes:
measure: Change in quality of life from pre-op to one year post-op
timeFrame: Baseline to 1 year post-op
Secondary outcomes:
measure: Changes in variables obtained from physical and radiological examination
timeFrame: Baseline to 1 year post-op
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri, MBBS, MS, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828461: Hoarding Disorder Treatment With Virtual Reality
Official title: Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarding Disorder
Hoarding
Clutter
Keywords: hoarding disorder
hoarding
clutter
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-02-04
Enrollment: 13
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study explores whether a facilitated peer support group called Buried in Treasures (BIT) and a virtual reality decluttering practice can help individuals with clutter challenges.

Detailed description: Individuals with clutter challenges participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that adding virtual reality decluttering practice to the BIT workshop will decrease hoarding symptoms and level of clutter over time.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 55
2. Either gender and all ethno-racial groups
3. Physically healthy male or non-pregnant female.
4. Hoarding Disorder primary condition
5. Willing and able to understand and complete consent and study procedures
6. English speaking
7. Participant should have the technology to host Zoom calls

Exclusion Criteria:

1. Current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year.
2. Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)
3. Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
4. Unable or unwilling to allow study staff into home for home assessment
5. Currently at high risk for eviction
6. Animal hoarding or squalor

Primary outcomes:
measure: Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)
timeFrame: Change from baseline to 16 weeks after treatment
Secondary outcomes:
measure: Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale
timeFrame: Change from baseline to 16 weeks after treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Psychiatry Department
state: California
Study officials:
affiliation: Stanford University
name: Carolyn I Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raila H, Avanesyan T, Valentine KE, Koo B, Huang C, Tsutsumi Y, Andreeff E, Qiu T, Munoz Rodriguez PA, Varias A, Filippou-Frye M, van Roessel P, Bullock K, Periyakoil VS, Rodriguez CI. Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults. J Psychiatr Res. 2023 Oct;166:25-31. doi: 10.1016/j.jpsychires.2023.08.002. Epub 2023 Aug 9.
Clinical trial NCT04055961: Atrial Fibrillation Ablation Registry
Official title: Atrial Fibrillation Ablation Registry Protocol Number: 3122-2016
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, 18 years and older, undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

Brief summary: The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF).

Detailed description: The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF). Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR™). The primary aims of the AFib Ablation Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous catheter ablation procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the AFib Ablation Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.

Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. 18 years and older
3. Undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

Exclusion Criteria:

1. none

Primary outcomes:
measure: Unsuccessful treatment rate
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoah Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Leila Andres
role: STUDY_CHAIR
References:
Clinical trial NCT05768061: HBV Reactivation in Anti CD20 Treatment
Official title: HBV Reactivation in Anti CD20 Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: anti CD20
Rituximab
HBV- hepatitis B virus
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 5000
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: The population of subjects who received anti-CD20 drugs as a treatment for a variety of diseases between the years 2000 to 2021, within Clalit Health care record database.

Brief summary: The goal of this observational study is to test and describe the frequency of hepatitis B virus reactivation in patients who received anti-CD20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.

Detailed description: Hepatitis B virus(HBV) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis B) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus.

Anti CD20 drug or Rituximab is an anti-CD20 monoclonal antibody on the surface of B lymphocytes, which induces cell death (apoptosis) and thus causes depletion. The main side effects of rituximab are infectious and hypersensitivity reactions. It can also increase the chance of hepatitis B reactivation to the point of acute hepatitis.

The information for this retrospective study will be collected from clalit health care's databases.

The patients will be sorted according to the indications for which the treatment with anti-CD20 drugs was given in order to see the differences in the response to the drug in different groups of patient

Eligibility criteria: Inclusion Criteria:

* subjects (men and women) of age 18 and above, who received anti-CD20 (Rituximab) drugs as a treatment for a variety of diseases .

Exclusion Criteria:

* healthy subjects.
* subjects under the age 18.
* subjects who did not receive anti CD20

Primary outcomes:
measure: HBV DNA in the blood.
timeFrame: about 10 minutes per blood test.
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
state: Tsafon
Study officials:
affiliation: haemek medical center
name: Rawi Hazzan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02285361: GIOTRIF rPMS in Korean Patients With NSCLC
Official title: A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 1272
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC in Korea

Brief summary: To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)


Eligibility criteria: Inclusion criteria:

1. Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to afatinib or any of its excipients
2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
3. Patients for whom GIOTRIF® is contraindicated according to the local label

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions (ADRs)
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Secondary outcomes:
measure: Progression-Free Survival (PFS) Rate at 48 Weeks
timeFrame: From week 0 until week 48. Up to 48 weeks.
measure: Percentage of Participants With Best Response
timeFrame: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
measure: Overall Survival (OS)
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: