louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01320605: Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies
Official title: TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Venous Leg Ulcer
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.


Eligibility criteria: Inclusion Criteria:

* Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation
* Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s)
* Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2
* Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®)
* Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments

Exclusion Criteria:

* Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900)
* Patients who have been previously treated with HP802-247
* Women of child-bearing potential
* Patients who are allergic to any of the components of HP802-247

Primary outcomes:
measure: Incidence of complete wound closure during the treatment period
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Overlook Hospital Wound Healing Program
state: New Jersey
Study officials:
References:
Clinical trial NCT06688305: 68Ga-NI-FAPI PET/CT: First-in-human Study
Official title: 68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.

Detailed description: Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.

Eligibility criteria: Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: safety and tolerability
timeFrame: up to 1 week
Secondary outcomes:
measure: Dosimetry of normal organs and tumors
timeFrame: From right after tracer injection to 150 minutes at post-injection
Other outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 3 months
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00021905: Atrial Fibrillation Incidence, Risk Factors and Genetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Hypertension
Cerebrovascular Accident
Arrhythmia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2001-08-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To assess the risk of incident atrial fibrillation after stopping anti-hypertensive medication including beta-blockers and ACE inhibitors. Also, to assess the role of genetics in subsequent risk of stroke among patients with atrial fibrillation.

Detailed description: BACKGROUND:

Prevention and treatment of atrial fibrillation (AF) is a significant public health issue. Atrial fibrillation affects 9 percent of persons aged 80 to 89. It is associated with elevated risk of stroke and death. The condition is likely to increase as survival rates from myocardial infarction continue to improve, prevalence of congestive heart failure grows, and treatment approaches evolve. The study will assess the safety of commonly used medications in relation to the risk of incident atrial fibrillation, and will assess the association of several genetic polymorphisms with stroke risk after AF onset. Several lines of evidence suggest that both beta-blockers and ACE inhibitors may prevent or inhibit the atrial electrical remodeling that allows AF to become established and maintained. Withdrawal of these medications may be associated with increased risk of AF in individuals at risk. Genetic polymorphisms that promote thrombosis are associated with an increased risk of venous thrombosis, and in some studies, with arterial thrombosis including stroke or myocardial infarction. Although several recently published trials indicate that warfarin or aspirin treatment of patients with AF decreases the risk of stroke, little is known about the risk of stroke as a complication of AF in relation to genetic variants that affect clotting.

DESIGN NARRATIVE:

The main tasks of the case-control study are: 1) identification of cases with incident AF and controls; 2) review of outpatient and inpatient medical records to assess eligibility and collect information on risk factors and medical history; 3) classification of medication use over time; 4) for AF patients, telephone interview and collection of blood samples; 5) blood specimen processing, DNA extraction, and genotyping; and 6) data analysis of the associations of medication use and genotype with AF onset and stroke complications.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Susan Heckbert
References:
citation: Glazer NL, Smith NL, Heckbert SR, Doggen CJ, Lemaitre RN, Psaty BM. Risk of myocardial infarction attributable to elevated levels of total cholesterol among hypertensives. Am J Hypertens. 2005 Jun;18(6):759-66. doi: 10.1016/j.amjhyper.2004.12.015.
Clinical trial NCT00318305: Patient Preference With Visicol Tablet Preparation for Colonoscopy
Official title: Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preparation for Colonoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: InKine Pharmaceutical
First posted: 2006-04-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scheduled colonoscopy list will be reviewed to identify potential subjects for recruitment. A cover letter will be sent to the potential study subject with tablet preparation as an alternative to Golytely preparation ( PEG). For subjects who are willing to participate, a prescription for 28 tablet sodium phosphate bowel preparation as outlined in appendix: A will be mailed. A questionnaire will be given to the patients prior to their colonoscopy to identify their preferences regarding bowel preparation and their acceptance ( see appendix: B).

A separate validated questionnaire will be given to participating physicians after the procedure, to quantitate the colonic cleansing (appendix : C). Adverse events will be documented. A statistical analysis of the results will be done at the end of the study.

Brief summary: The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.


Eligibility criteria: Inclusion Criteria:

* Prior colonoscopy with PEG solution in the past one year
* Must be able to swallow tablets

Exclusion Criteria:

* Patients below 18 years and above 100 years.
* Congestive heart failure
* Chronic renal failure
* Pre-existing electrolyte disorder
* Pre-existing mega-colon or a motility disorder.
* Patients with pre-existing seizure disorder.
* Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study.
* Pregnant or lactating women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Suryakanth R. Gurudu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218998: Effective Endurance Training in Metabolic Syndrome
Official title: Effective Endurance Training in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Overweight
Hypertension
Dyslipidemia
Keywords: Exercise
Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To see how fast and how much physical training can reduce risk factors related to metabolic syndrome


Eligibility criteria: Inclusion Criteria:

* insulin resistance, impaired glucose tolerance or type 2-diabetes, including two or more of the following factors: Blood pressure ≥ 140/90 mm Hg, Triglycerides Fasting ≥ 1,7 mmol/l, and/or low HDL-cholesterol (≤ 0,9 mmol/l in men, ≤ 1,0 mmol/l in women)
* Obesity, Waist-hip ratio ≥ 0,9 in men, ≥ 0,85 in women or BMI (body mass index) ≥ 30 kg/m2
* Microalbuminuria (albumin secretion ≥ 20 mg/l or 20 - 200 g per minute)

Exclusion Criteria:

-

Primary outcomes:
measure: To reduce risk factors related to metabolic syndrome
Secondary outcomes:
measure: Improve endothelial functions in patient with metabolic syndrome
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: The medical faculty at norwegian university of science and technology
Study officials:
affiliation: National Taiwan Normal University
name: Ulrik E Wisløff, Phd prof
role: STUDY_CHAIR
References:
citation: Poelkens F, Hopman MT, Tack CC. Letter by Poelkens et al regarding article, "Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study". Circulation. 2009 Mar 3;119(8):e225; author reply e226. doi: 10.1161/CIRCULATIONAHA.108.818765. No abstract available.
citation: Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slordahl SA, Kemi OJ, Najjar SM, Wisloff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008 Jul 22;118(4):346-54. doi: 10.1161/CIRCULATIONAHA.108.772822. Epub 2008 Jul 7.
Clinical trial NCT01578798: Detection of Immune Changes as a Result of Surgical Trauma in Human Subject
Official title: Detection of Immune Changes as a Result of Surgical Trauma in Human Subject
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Trauma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary hip replacement.

Brief summary: Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study to characterize the cellular and molecular mechanisms immune response to surgical trauma. Additionally, detailed information about patients' recovery profile will be recorded over a period of 6 weeks, with the eventual goal of linking immune responses to recovery profiles.


Eligibility criteria: Inclusion Criteria:

* 18 - 90
* Planning to undergo hip surgery
* Fluent in English
* Willing and able to sign informed consent and HIPAA authorization

Exclusion Criteria:

* Any systemic disease that might compromise the immune system
* Diagnosis of cancer within the last 5 years
* Psychiatric, immunological, and neurological conditions that would interfere with the collection and interpretation of study data
* Pregnancy
* Any other conditions that, in the opinion of the investigators, may compromise a participant's safety or the integrity of the study

Primary outcomes:
measure: Mass cytometry of immune signaling events
timeFrame: Blood samples for mass cytometry will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.
Secondary outcomes:
measure: Surgical Recovery Scale (SRS)
timeFrame: Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.
measure: Plasma cytokines
timeFrame: Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University
name: Martin S Angst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
Clinical trial NCT00537498: Urokinase Therapy in Diabetic Foot Syndrome
Official title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot
Arterial Occlusive Disease
Ischemia
Keywords: urokinase, diabetes, wound healing, major amputation
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.

Detailed description: Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.

Eligibility criteria: Inclusion Criteria:

* angiopathic or angioneuropathic diabetic foot lesions
* critical limb ischemia
* no surgical or interventional treatment option

Exclusion Criteria:

* feasibility of vascular surgery or angioplasty
* prior treatment of the current ulceration with urokinase
* need for dialysis
* creatinine \> 180µmol/l
* any kind of cerebral event less than three months before inclusion into the study
* proliferative retinopathy (not remediated)
* uncontrolled hypertension
* hemorrhagic diathesis
* gastrointestinal bleeding
* need for oral anticoagulation
* mental disorders
* pregnancy
* participation in another study

Primary outcomes:
measure: Number of patients being alive, having no major amputation and healed ulceration
timeFrame: 12 months
Secondary outcomes:
measure: Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum
Study officials:
affiliation: Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum
name: Sebastian M. Schellong, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455398: Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
Official title: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Sudden
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, ≤ 65 years old
2. The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region.
3. Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve inner ear circulation, but have not responded to treatment (PTA improvement \< 15 dB).
4. No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy; no general anesthesia - contraindication.
5. Patients voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, syndromic deafness malignant tumors.
2. Pregnant and lactating women.
3. Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction.
4. Any other conditions that the investigator believes should be excluded from this study.

Primary outcomes:
measure: Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Zhigang ZHANG, master
role: STUDY_DIRECTOR
References: