louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00073450: Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
Official title: An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Squamous Cell
Head and Neck Neoplasms
Keywords: Squamous Cell Carcinoma of the Head & Neck
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2003-11-24
Enrollment: 15
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 purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head \& Neck and will help determine if further development is justified.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head \& neck.
* Age greater than or equal to 18.
* ECOG performance status of 0 to 1
* Measurable malignant disease.
* Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
* Patients must be at least 2 wks post surgery or radiation therapy
* Patients must be at least 4 weeks post chemotherapy
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient.
* Appropriate use of effective contraception if of childbearing potential.
* No investigational drugs of any type within 30 days prior to administration.

Exclusion Criteria:

* Prior exposure to farnesyl transferase inhibitors
* Medical conditions that would interfere with taking oral medications.
* Patients with significant QTc prolongation at baseline (\>500 msec.)
* Pregnant or nursing women
* Known HIV positivity or AIDS-related illness.
* Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
* Patients with any signs of involvement of the dura, meninges, or brain.
* Patients with squamous cell carcinoma of the nasopharynx
* Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hanrahan EO, Kies MS, Glisson BS, Khuri FR, Feng L, Tran HT, Ginsberg LE, Truong MT, Hong WK, Kim ES. A phase II study of Lonafarnib (SCH66336) in patients with chemorefractory, advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2009 Jun;32(3):274-9. doi: 10.1097/COC.0b013e318187dd57.
Clinical trial NCT02644850: Comparison of Gated Blood-pool SPECT and Echocardiogram for Ventricular Function
Official title: Comparison of Gated Blood-pool SPECT Using CZT Camera and Echocardiogram for Ventricular Ejection Fraction Estimation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Dysfunction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other

Brief summary: To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.

Detailed description: To evaluate the feasibility of using CZT SPECT as an "all-in-one" technique to provide information on both left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) derived from a single examination and compare with the values from traditional planar ERNA, FP-RNV and echocardiography.

Eligibility criteria: Inclusion Criteria:

* Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Measure the biventricular ejection fraction
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital and National Taiwan University College of Medicine
Study officials:
affiliation: National Taiwan University Hospital and National Taiwan University College of Medicine
name: Mei-Fang Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204150: Study to Image the Esophagus Using the OFDI Capsule
Official title: Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Eosinophilic Esophagitis
Keywords: Optical Coherence Tomography
Barrett's Esophagus
Esophagus
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2014-07-30
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Detailed description: A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Eligibility criteria: Inclusion Criteria:

* A previous diagnosis of Barrett's Esophagus
* OR a previous diagnosis of EoE
* OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
* Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with known esophageal strictures, intestinal strictures or dysphagia
* OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

Primary outcomes:
measure: Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule
timeFrame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005250: Linkage Study of Long QT Syndrome In An Amish Kindred
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Cardiovascular Diseases
Tachycardia, Ventricular
Ventricular Fibrillation
Long QT Syndrome
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To screen by electrocardiography the entire population of 1,400 individuals in seven Amish Mennonite communities in order to perform genetic linkage studies of long QT syndrome (LQTS).

Detailed description: BACKGROUND:

LQTS is a severe heart disorder leading to sudden death due to ventricular tachycardia or ventricular fibrillation. The syndrome segregated as a Mendelian recessive in the highly inbred population under study and resulted in the sudden death of several members of the population.

DESIGN NARRATIVE:

The entire population was screened to identify cases of LQTS. In addition, 29 obligate heterozygotes were studied by 24-hour Holter monitoring to determine whether these gene carriers had any subtle phenotypes. The data were subjected to complex segregation and linkage analysis to establish the mode of inheritance and penetrance of LQTS.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00898950: Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
Official title: The Links Between Dysglycaemia, Insulin Resistance, Endothelial Function, Inflammation and Oxidative Stress: Effect of Different Doses of Aspirin in Subjects With Type-2 Diabetes and High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: diabetes
aspirin
oxidative stress
insulin resistance
endothelial function
inflammation
photoplethysmography
dysglycaemia
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied.


Eligibility criteria: Inclusion Criteria:

* diabetes type 2
* age \> 18 and \< 70
* high cardiovascular risk

Exclusion Criteria:

* presence of active/established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)
* insulin treatment
* patients with known peptic ulcer disease or those on anti-coagulation
* significant renal impairment
* aspirin intolerance
* use of anticoagulants
* significant liver disease

Primary outcomes:
measure: Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in inflammatory markers
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: School of Pharmacy and Biomedical Sciences, University of Posrtmouth
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Rajeev P Raghavan, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Portsmouth Hospitals NHS TRust & University of Portsmouth
name: Michael H Cummings, MD, FRCP
role: STUDY_DIRECTOR
References:
citation: Raghavan RP, Laight DW, Cummings MH. Aspirin in type 2 diabetes, a randomised controlled study: effect of different doses on inflammation, oxidative stress, insulin resistance and endothelial function. Int J Clin Pract. 2014 Feb;68(2):271-7. doi: 10.1111/ijcp.12310. Epub 2013 Dec 22.
Clinical trial NCT02499250: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients
Official title: Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients and the Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Angina Pectoris
Keywords: refractory angina pectoris
remote ischemic conditioning
life quality
anxiety
depression
inflammation
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose is to test whether daily ischemic conditioning of the arms over 30 days could reduce the frequency and severity of angina pectoris and improve the life quality of refractory angina pectoris patients.

Detailed description: Refractory angina pectoris denotes "chronic stable angina that persists despite optimal medication and when revascularisation is unfeasible or where the risks are unjustified". These patients could potentially be relieved by non-conventional treatments like remote ischemic conditioning, and actually this effect has been observed in several cases in the center of the sponsor. This study is a pilot study to measure the efficacy and safety of this method in this group of patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed angina pectoris that remains despite optimal medical treatment;
* No chance of further revascularization or refusal to do revascularization;
* The frequency and Canadian Cardiovascular Society (CCS) scale stays stable over the past 3 months before inclusion.

Exclusion Criteria:

* Known or highly suspected abnormality of peripheral arteries, veins, or extremities;
* Infection or fever in the past month;
* Blood pressure over 180/110 millimeters of mercury (mmHg) or below 80/50mmHg;
* Refusal to comply with the study protocol;
* Currently under sulfonylureas or prostaglandins therapy;
* Other conditions that the researchers judge as inappropriate to participate.

Primary outcomes:
measure: Frequencies of angina pectoris onset
timeFrame: 30 days
measure: Canadian Cardiovascular Society Angina Class
timeFrame: 30 days
Secondary outcomes:
measure: Flow mediated vasodilation in percentage increase
timeFrame: 30 days
measure: Flow mediated vasodilation in absolute increase
timeFrame: 30 days
measure: Self-Rating Anxiety Scale
timeFrame: 30 days
measure: Self-Rating Depression Scale
timeFrame: 30 days
measure: Inflammatory cytokines expression
timeFrame: 30 days
measure: Grip strength
timeFrame: 30 days
measure: Skin and muscle abnormalities
timeFrame: 1,7 and 30 days
measure: Circulating CD34+ progenitor cells
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Heart Center, Navy General Hospital of PLA
state: Beijing
Study officials:
affiliation: Heart center, Navy General Hospital
name: Tianchang Li, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06681350: Occyo Tele-ophthalmology Study
Official title: Evaluation of Diagnostic Effectiveness and Reliability of a Telemedical Examination with Occyo One Vs Traditional Slit Lamp-based Examination After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Keywords: Cataract
Slit lamp
Telemedical examination
Image based diagnosis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 365
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prospective, (observer) blinded clinical trial at the University Hospital for Ophthalmology includes patients routinely scheduled for cataract surgery at the Medical University of Innsbruck.

Patients are enrolled one week prior to their planned cataract surgery. The participants will undergo a screening in which, in addition to the ophthalmological standard examinations, Occyo One images of the anterior segment of the eye are taken. After surgery, a post-operative follow-up visit takes place and a second set of Occyo One images will be generated.

During the postoperative check-up, the study team at the trial center decides-based on defined criteria (medical history, slit lamp examination results)-whether a change in the subsequent patient management is necessary due to the presence of postoperative complications (unexpected management changes = UMC).

Up on completion of all patient visits/study-specific measurements and data collection, information regarding diagnostic criteria and the Occyo One images are sent to an external, blinded ophthalmologist for telemedical assessment. Based on the available information and images, the blinded ophthalmologist decides whether a change in patient management should have been made or not.

The difference in the detection of an event resulting in a UMC is the primary objective of this clinical investigation.


Eligibility criteria: Inclusion Criteria:

1. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
2. Patients scheduled to undergo cataract surgery
3. Male or female patient aged ≥ 50 years at time of consent

Exclusion Criteria:

1. Woman of childbearing potential (WOCBP)

Primary outcomes:
measure: Unexpected Management Changes
timeFrame: 1 week
Secondary outcomes:
measure: Efron Grading
timeFrame: 1 week
measure: Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema
timeFrame: 1 week
measure: National Eye Institute (NEI) Grading Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
Study officials:
References:
Clinical trial NCT01353950: Costimulatory Molecules as Biomarkers in Cystic Fibrosis
Official title: Costimulatory Molecules as Biomarkers in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Costimulatory molecules
Cystic Fibrosis
Biomarkers
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Cystic Fibrosis

Brief summary: The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.


Eligibility criteria: Inclusion Criteria:

* Willingness to participate

Exclusion Criteria:

* Presence of HIV
* Presence of Lymphoma/Leukemia
* Presence of Lung or other solid organ Transplant
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon health and Sciences University
state: Oregon
Study officials:
References:
Clinical trial NCT07020650: The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation
Official title: The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healing Wound
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.

Detailed description: Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.

45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.

Eligibility criteria: Inclusion criteria:

* Age between 20 and 80 years old
* Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.
* Extraction sockets must be infection-free with dehiscence less than 5mm.
* Patients interested in implant placement after tooth extraction.

Exclusion criteria:

* Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)
* Hematologic disorders or blood dyscrasias.
* Active infectious diseases.
* Liver or kidney dysfunction/failure.
* Uncontrolled diabetes (i.e., HbA1c \> 8).
* Undergoing active cancer treatment, including chemotherapy or radiotherapy within the last 12 months from the procedure.
* Use of medications affecting bone healing (e.g., bisphosphonates, long-term anti-inflammatory medications).
* Metabolic bone diseases affecting bone healing, such as osteoporosis (self-reported).
* Pregnant or lactating women (self-reported).
* Current smokers of 10 or more cigarettes per day and former smokers who quit less than 10 years ago (self-reported).
* Poor oral hygiene.
* Presence of fenestration defects equal to or greater than 5mm.

Primary outcomes:
measure: Clinical alveolar ridge dimension changes
timeFrame: 4 months
Secondary outcomes:
measure: Histological bone density
timeFrame: 4 months
measure: Presence of bone turnover proteins
timeFrame: 4 months
measure: Alveolar volumetric changes following tooth extraction
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hom-Lay Wang, DDS,MSD,PhD
role: PRINCIPAL_INVESTIGATOR
References: