louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005261: Urinary Kallikrein and Hypertension: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine whether low total urinary kallikrein activity was prospectively associated with new hypertension onset or elevated blood pressures.

Detailed description: BACKGROUND:

Statistical evidence had been found for a dominant major gene segregating in large pedigrees for high urinary kallikrein levels protecting against hypertension which explained 51 percent of the variance of total urinary kallikrein (TUK). In normotensive adult and pediatric pedigree members, low urinary kallikrein activity was associated with a positive family history of hypertension, stroke, and/or coronary disease.

DESIGN NARRATIVE:

The presence of a previously reported dominant major gene inferred from segregation analysis of total urinary kallikrein activity (TUK) in selected pedigrees was verified on already collected frozen urine specimens. Subjects were rescreened to obtain measured nine year follow-up blood pressure data. Individuals were classified by assigned baseline TUK genotype and tested to determine whether low TUK was prospectively associated with new hypertension onset or elevated blood pressures. Because a major gene effect was implicated, available probes for the structural kallikrein gene or other related products regulating kallikrein were tested for genetic linkage to TUK levels. Correlations with over 600 variables measured at baseline in pedigrees and twins were tested to analyze the strong familiality of environment, refine the genetic analyses to better assign genotypes, and detect gene-environment interactions. All baseline variables except kallikrein, aldosterone, and prostaglandin measurements on frozen urine and follow-up blood pressure had already been collected.

TUK may be a marker for a renal, cellular or other physiological abnormality influencing both TUK expression and susceptibility to hypertension. Therefore, the relationship of TUK to urinary aldosterone, prostaglandin E excretion and already measured urinary electrolytes, plasma renin activity, and baseline and reactive blood pressures was determined. Genetic segregation analyses were performed of the urinary variables and other variables closely associated with TUK.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hunt SC, Wu LL, Slattery ML, Meikle AW, Williams RR. Environmental determinants of urinary kallikrein excretion. Am J Hypertens. 1993 Mar;6(3 Pt 1):226-33.
Clinical trial NCT05155761: Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Official title: Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall
Fall Patients
Osteoporosis
Keywords: FeetMe
Insoles
Fall
Osteoporosis
Lead sponsor: FeetMe
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.

Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.

At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).

The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.


Eligibility criteria: Inclusion Criteria:

* male and female subjects aged 60 years and above
* with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)
* a fall within the last year, who own a smartphone.

Exclusion Criteria:

* cognitive deficit or concomitant disorder limiting communication or participation in the study
* simultaneous participation in another study
* deprivation of liberty due to a legal or administrative decision
* patients receiving psychiatric care
* adults beyond the age of majority under legal protection measures or unable to express their consent
* patients admitted to a health or social establishment for reasons other than research.

Primary outcomes:
measure: To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de
Study officials:
References:
Clinical trial NCT02304861: Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss
Official title: Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
viscoelastic (OVD) technology
endothelial cell count
endothelial cell pattern
central corneal edema
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Objective of this study is the comparative assessment of the beneficial impact of the Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following torsional-ip cataract extraction surgery.

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer randomization program all participants will randomly populate two study groups according to the OVD used (ie. viscoat or visthesia).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of senile cataract with stage 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

* Endothelial cell count less than 1900,
* glaucoma,
* IOP-lowering medications,
* former incisional surgery,
* former diagnosis of corneal disease,
* diabetes or autoimmune diseases

Primary outcomes:
measure: Endothelial Cell Count (ECD)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Endothelial Cell pattern (ECP)
timeFrame: 3 months postoperatively
measure: Central corneal edema (CCE)
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Sideroudi H, Rousopoulos K, Kozobolis VP. Cohesive versus dispersive-cohesive ophthalmic viscosurgical device in torsional intelligent phaco. J Cataract Refract Surg. 2015 Mar;41(3):681-2. doi: 10.1016/j.jcrs.2015.01.010. No abstract available.
Clinical trial NCT03100461: Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Official title: Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer Screening
Colon Cancer
Colon Cancer Screening
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.

Detailed description: Colorectal Cancer is preventable and curable but is still the second most common cause of cancer death in the U.S. Minorities and those with low income have more CRC than middle and high income Whites.. They also get fewer CRC screening tests. Low knowledge of CRC screening may, in part, drive this lower test use. We need new ways to improve CRC screening in primary care clinics where many minority and uninsured patients receive health care.

Eligibility criteria: Inclusion Criteria:

* Have a home address and access to a working telephone
* Pass Mini-Cog assessment

Exclusion Criteria:

* FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
* Acute medical illness,
* current GI bleed
* history of adenomatous polyps
* Colorectal Cancer
* 1st degree relative with CRC \< age 60 years
* inherited polyposis/non-polyposis syndrome
* inflammatory bowel disease
* Another household member enrolled in the study

Primary outcomes:
measure: CRC screening completion rate
timeFrame: 12-14 Months
Secondary outcomes:
measure: Cost analysis of each intervention pathway
timeFrame: 14 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Allen Greiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395561: Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Official title: the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Survivors
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic inflammation and oxidative stress in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, adropin, irisin, vaspine, systemic inflammation and oxidative stress will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40 treatment is over

Exclusion Criteria:

* Taking any kind of supplement for weight reduction
* pregnancy or lactation
* Professional athletes

Primary outcomes:
measure: Tumor necrosis factor alpha
timeFrame: 12 weeks
measure: Interleukin 6
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT02264561: Caffeine's Effect on Attention
Official title: The Effect of Caffeine on Attention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine whether caffeine improves attention.

Detailed description: Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo

Eligibility criteria: Healthy male and female Aged 40-60 years

Primary outcomes:
measure: Attention test: milliseconds and index of stimulus sensitivity
timeFrame: duration 10 days from screening to last visit (V2)
Secondary outcomes:
measure: Central Nervous System :response time.
timeFrame: duration: 10 days from screening to last visit (V2)
measure: Mood measures: Visual Analog scale.
timeFrame: duration 10 days from screening to last visit V2
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Center for Human Drug Research
state: CL
Study officials:
References:
Clinical trial NCT03686761: Periodontal Changes Following Mid Maxillary Distraction
Official title: Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Periodontal Pocket
Attachment Loss, Periodontal
Keywords: Inflammation
Healing
Distraction
Periodontium
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2018-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
Primary purpose: TREATMENT

Brief summary: To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

Detailed description: Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.

Eligibility criteria: Inclusion Criteria:

* Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria:

* Systemic disease

Primary outcomes:
measure: Measurement of periodontal inflammatory mediators
timeFrame: 7 days
Secondary outcomes:
measure: Measurement of periodontal inflammatory mediators TNF- α
timeFrame: 7 days
measure: Assessment of periodontal probing depth
timeFrame: 3 and 6 month
measure: Assessment of clinical attachment loss
timeFrame: 3 and 6 month
measure: Assessment of periodontal clinical parameters
timeFrame: 3 and 6 month
Other outcomes:
measure: Evaluating the gingival histological changes
timeFrame: 2 and 4 weeks
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Alexandria University
name: Marwa Madi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00601861: Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer
Official title: A Single Arm, Single-centre, Open-label, Exploratory Trial of Recombinant Interleukin-21 Administered Subcutaneously for 4 Weeks as Neo-adjuvant Treatment Prior to Sentinel Lymph Node/Complete Lymph Node Dissection Followed by 8 Weeks of Adjuvant Treatment in Subjects With Stage III Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Malignant Melanoma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

Detailed description: The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.

Eligibility criteria: Inclusion Criteria:

* Stage III melanoma
* ECOG performance status 0-1

Exclusion Criteria:

* Signs of stage IV melanoma
* Safety variables

Primary outcomes:
measure: Complete pathological response rate in the lymph nodes
timeFrame: After 4 weeks of treatment
Secondary outcomes:
measure: Safety
timeFrame: For the duration of the trial
measure: Immunomodulatory effects
timeFrame: For the duration of the trial
measure: Relapse free survival
timeFrame: For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00035061: A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urologic Neoplasms
Metastases, Neoplasm
Keywords: Bladder Cancer
Metastatic
Recurrent
Transitional cell carcinoma of the urothelium
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.


Eligibility criteria: Inclusion Criteria:

* You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body.
* You must have at least one tumor that can be physically measured or scanned by x-ray.
* You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago.

Exclusion Criteria:

* You may not have used an experimental medicine or device within the past month.
* Cancer that has spread to your brain.
* If you are unwilling or unable to take folic acid or vitamin B12 supplements.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Lenexa
country: United States
state: Kansas
city: Saint Mathews
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT01871961: Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
Official title: Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2013-06-07
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).


Eligibility criteria: Inclusion Criteria:

* Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
* Male or female patient who is 16 years of age or older

Exclusion Criteria:

* Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
* Has any history of hypersensitivity to the investigational medicinal product
* Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
* Is unable to comprehend written labeling and training materials

Primary outcomes:
measure: To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Rheumatology Arthitis & Rheumatic Care center
state: Florida
Study officials:
References: