louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03524404: BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT
Official title: BRInging the Diabetes Prevention Program to GEriatric Populations(BRIDGE): a Pilot Study to Test the Usability and Effectiveness of a Telehealth Adaption of the Diabetes Prevention Program (DPP) in a Community of Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.


Eligibility criteria: Inclusion Criteria:

* Men and women age ≥ 60 years
* Diabetes Risk Score \>=5

Exclusion Criteria:

* Decisional incapacity to consent

Primary outcomes:
measure: Program engagement
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: Jeannette.Beasley@nyumc.org
name: Jeannette Beasley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beasley JM, Kirshner L, Wylie-Rosett J, Sevick MA, DeLuca L, Chodosh J. BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. Pilot Feasibility Stud. 2019 Nov 11;5:129. doi: 10.1186/s40814-019-0513-7. eCollection 2019.
Clinical trial NCT02229604: Electroacupuncture for Diminished Ovarian Reserve
Official title: Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irregular Menses
Keywords: electroacupuncture
diminished ovarian reserve
cohort study
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 57
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.


Eligibility criteria: Inclusion Criteria:

* Age younger than 40 yr
* 10IU/L ≤ FSH ≤ 40IU/L
* Volunteer to join the research and give the informed consent

Exclusion Criteria:

* A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation
* Reproductive system infection or tumor
* Autoimmune disease
* Amenorrhea due to reproduction abnormality or pregnancy
* Patients can not adhere to treatment due to personal situation
* Patients have taken immunosuppressive agents in past 6 months
* receive treatment for less than 1 week before withdrawal

Primary outcomes:
measure: change of FSH from baseline
timeFrame: baseline, week 12
Secondary outcomes:
measure: change of FSH level from baseline
timeFrame: baseline, week 4, 8, 16, 20, and 24
measure: changes in FSH/LH ratio, LH, and E2 from baseline
timeFrame: baseline, week 4, 8, 12, 16, 20, and 24
measure: change of symptom scale
timeFrame: baseline, week 12, week 24
measure: proportion of patients regaining regular menses
timeFrame: baseline, weeks 8, 12 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu, Ph.D
role: STUDY_CHAIR
References:
citation: Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.
Clinical trial NCT01746004: A Study of LY2157299 Monohydrate in Healthy Volunteers
Official title: Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.


Eligibility criteria: Inclusion Criteria:

* Healthy surgically sterile females, postmenopausal females, or sterile males
* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2)
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Have known allergies to LY2157299, related compounds or any components of the formulation
* Have an abnormal blood pressure as determined by the investigator
* Have participated in a \[\^14C\]-study within the last 6 months prior to admission for this study

Primary outcomes:
measure: Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Pre-dose through Day 15
Secondary outcomes:
measure: Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)
timeFrame: Pre-dose through Day 14
measure: Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)
timeFrame: Pre-dose through Day 14
measure: Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)
timeFrame: Pre-dose through Day 14
measure: Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces
timeFrame: Pre-dose through Day 14
measure: Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma
timeFrame: Pre-dose through Day 14
Other outcomes:
Locations:
city: Madison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03101904: The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Official title: The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Bangor University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study will aim to describe and evaluate the effect of chronic beetroot juice supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It is hypothesized that beetroot supplementation will decrease acute mountain sickness and increase exercise performance.


Eligibility criteria: Inclusion Criteria:

* Women only: Regular menstrual cycle or post-menopausal

Exclusion Criteria:

* Stayed at altitude above 2500m in the last 6 months
* Traveled to altitude above 2500m in the last 2 months
* Unable to give informed consent
* Unstable medical condition.

Primary outcomes:
measure: Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire.
timeFrame: Measured on the fifth day of supplementation with a six-hour exposure to hypoxia
Secondary outcomes:
measure: Hypoxic Exercise Performance as Assessed by Time to Exhaustion at 80% of Hypoxic V̇O2max Reserve.
timeFrame: Measured on the sixth day of supplementation
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: School of Sport, Health and Exercise Sciences, Bangor University
state: Gwynedd
Study officials:
affiliation: Bangor University
name: Jamie H Macdonald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampson JB, Kobrick JL, Johnson RF. Measurement of subjective reactions to extreme environments: the Environmental Symptoms Questionnaire. Military Psychology. 1994; 6(4):215-233. doi: 10.1207/s15327876mp0604_2
Clinical trial NCT04585204: Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM
Official title: Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Glucose Intolerance During Pregnancy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 2282
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.


Eligibility criteria: Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Already diagnosed by diabetes mellitus
* Multiple pregnancy

Primary outcomes:
measure: the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT05310604: Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.
Official title: Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Antibody Deficiencies
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.

Brief summary: Rationale: Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous diseases. The clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. Due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity, mortality and health care costs as effective therapies are available. The currently available screening systems for the broader group of primary immunodeficiencies (PID) have been shown to have poor diagnostic performance5-10 and are time consuming. We have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for PAD. Patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of PAD. The aim of the current study is to validate this algorithm.

Objective:

Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands.

Study design: Mono-centre cohort study based on regular care data

Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.


Eligibility criteria: Inclusion Criteria:

* Age between 12 and 70 years
* A total algorithm score that is within the highest 0.66% of the algorithm scores within a single general practitioner's clinic
* Signed informed consent
* Did not meet exclusion criteria during manual evaluation of the health care record

Exclusion Criteria:

* Secondary causes of immunodeficiency as registered by ICPC codes for: multiple myeloma, HIV-infection, anorexia nervosa, bulimia, cystic fibrosis.
* The presence of one of the following during manual screening of the health care record: nephrotic syndrome, current systemic chemotherapy and stage 3-4 liver cirrhosis will be excluded. This could not be done by the algorithm as there is no ICPC code available.

Primary outcomes:
measure: The percentage of high-risk patients with an eventual PAD diagnosis
timeFrame: measurement december 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
Clinical trial NCT01179204: Prediction of Pain in Total Knee Arthroplasty
Official title: Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated with total knee arthroplasty (TKA)

Brief summary: In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

Detailed description: The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Eligibility criteria: Inclusion Criteria:

* Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.

Exclusion Criteria:

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of opioids or glucocorticoids
* Malignancy
* BMI \> 40
* Depression
* Dementia or other cognitive dysfunction

Primary outcomes:
measure: Cumulated pain (from 0-24 hours after surgery)
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulated pain (from day 1 to day 7 after surgery)
timeFrame: 7 days
measure: Pain at day 14 after surgery
timeFrame: 14 days
measure: Pain at day 30 after surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Troels H. Lunn, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365104: Modulation of Cerebral Blood Flow Using Iron Chelators
Official title: Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Problem of Aging
Keywords: brain blood flow
stroke
cerebrovascular
aging
cerebrovascular hemodynamics
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-06-03
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Eligibility criteria: Inclusion Criteria:

* healthy adults between the ages of 18-80 years.

Exclusion Criteria:

* subjects taking vasoactive medications,
* hypertension,
* pregnant women, smokers,
* COPD,
* asthma,
* diabetes mellitus,
* intracranial or carotid stenosis,
* hepatic disease,
* renal disease,
* bone marrow suppression,
* cardiac disease,
* heart failure,
* iron deficiency,
* history of cancer,
* history of head trauma,
* subarachnoid hemorrhage,
* central nervous system vasculitis,
* multiple sclerosis,
* migraines,
* seizures,
* sickle cell disease or trait,
* cardiac arrhythmia,
* unable to give informed consent, or
* poor transcranial Doppler insonation windows.

Primary outcomes:
measure: Define change from baseline cerebral blood flow after receiving DFO infusion.
timeFrame: baseline, 3hr, 6hr, 9hr
measure: Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.
timeFrame: baseline, 3hr, 6hr, 9hr
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Farzaneh Sorond, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.
Clinical trial NCT05400304: Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma
Official title: Preoperative CT-based Radiomics Combined With Intraoperative Frozen Section is Predictive of Spread Through Air Space in Early Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Keywords: Spread Through Air Space
radiomics
frozen section
Prediction Model
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary nodules in the collaborating institutes.

Brief summary: a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Detailed description: Spread through air space (STAS) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics and frozen section haave been recently proposed to predict STAS in patients with lung adenocarcinoma. Radiomics-based Prediction Model is highly sensitive but not specific for STAS detection. While, frozen section is highly specific but not sensitive for STAS detection in early lung adenocarcinomas.

Therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Eligibility criteria: Inclusion Criteria:

1. intraoperative frozen section diagnosis and final pathology diagnosis are available
2. preoperative standard non-enhanced CT is available
3. Pathologically confirmed

Exclusion Criteria:

1. with a previous history of radiation therapy, chemotherapy or biopsy
2. the time interval between the CT examination and surgery was more than two weeks

Primary outcomes:
measure: Sensitivity
timeFrame: 24 hour before operation
measure: Specificity
timeFrame: 24 hour before operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: