louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162357: Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
Official title: Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Coronary Restenosis
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.


Eligibility criteria: Inclusion Criteria:

* Type II Diabetes on medication \& angioplasty within the past 6 months.

Exclusion Criteria:

* Myocardial infarction or repeat angioplasty with the past 5 months.
* Unable to perform exercise or pharmacologic stress test.

Primary outcomes:
measure: Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary outcomes:
measure: Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
measure: Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.
measure: Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Local Institution
state: Connecticut
city: Waterbury
country: United States
facility: Local Institution
state: Connecticut
city: Grand Rapids
country: United States
facility: Local Institution
state: Michigan
city: Roslyn
country: United States
facility: Local Institution
state: New York
city: Burlington
country: United States
facility: Local Institution
state: Vermont
city: Roanoke
country: United States
facility: Local Institution
state: Virginia
city: Wausau
country: United States
facility: Local Institution
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Lantheus Medical Imaging
name: Qi Zhu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00215657: Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Official title: An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 131
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Detailed description: Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Eligibility criteria: Inclusion Criteria:

* Males aged 18 or over
* Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
* Has completed Study FE200486 CS07
* Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

Primary outcomes:
measure: Liver Function Tests
timeFrame: 3 years
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT04776057: Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Official title: Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Astigmatism
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Detailed description: To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Eligibility criteria: Inclusion Criteria:

* Cataract
* Age 21 and older
* Regular corneal astigmatism ≥ 1.5 D
* written informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* High myopia (\> 29 mm AL)
* Irregular corneal astigmatism on corneal topography
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Primary outcomes:
measure: Comparison of toric IOL rotation between both groups (mean ≠ SD)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanusch Hospital, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT04061057: Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia
Official title: Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

1. ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair

Exclusion Criteria:

1. Known allergies to lidocaine or propofol
2. Cardia arrhythmia
3. History of epilepsy or seizures
4. Liver/kidney failure
5. History of recent strong opioid use

Primary outcomes:
measure: Fentanyl requirement using IV PCA
timeFrame: 24hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: Kim SJ, Choi YS, Chun YM, Kim HJ, Han C, Shin S. Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia: A Randomized Controlled Trial. Clin J Pain. 2021 Oct 12;38(1):1-7. doi: 10.1097/AJP.0000000000000995.
Clinical trial NCT05809557: EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity
Official title: Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Chemotherapeutic Toxicity
Metastatic Solid Tumor
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Providers, who were selected based on having at least 20 new patients with metastatic solid tumors in a 6-month period in 2021, will be randomized in a 1:1 ratio, stratified by quartiles of patient volume.
Primary purpose: PREVENTION

Brief summary: This study will formally test the quality improvement intervention of an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.


Eligibility criteria: Inclusion Criteria:

* New outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment.
* aged \> 65 will be included.

Exclusion Criteria:

* Patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). Specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out.
* Patients with no EHR data after initial oncologist appointment.

Primary outcomes:
measure: Unplanned hospitalization rate
timeFrame: Within 3 months of the Index Visit with the oncologist
Secondary outcomes:
measure: Healthcare contact days
timeFrame: Within 3 and 6 months of the Index Visit with the oncologist
measure: Chemotherapy use rate
timeFrame: Within 3 months of the Index Visit with the oncologist
measure: Chemotherapy modification rate
timeFrame: Within 3 months of the Index Visit with the oncologist
measure: Palliative Care Referral
timeFrame: Within 6 months of the Index Visit with the oncologist
measure: Chemotherapy toxicity tool use rate
timeFrame: Within 3 months of the Index Visit with the oncologist
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03099057: Study of Prognostic Factors in Interventional Rhythmology
Official title: Study of Prognostic Factors in Interventional Rhythmology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 2805
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: Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest

Brief summary: Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm

Detailed description: To assess the fate of patients who have undergone a technical procedure at the Cardiology Plate (implantation / extraction of a pacemaker, a defibrillator, radiofrequency ablation or cryo-ablation, left auricle closure, electro- Physiological exploration), and to determine prognostic factors / markers in this population.

Eligibility criteria: Inclusion Criteria:

Patient to undergo:

* Implantation of a cardiac pacemaker or cardiac defibrillator or
* Extraction of pacemaker / defibrillator housing or probes or
* Realization of a radiofrequency / cryo-ablation:
* Atrial fibrillation
* Focus of ventricular tachycardia
* An accessory or
* Any electrophysiological exploration or
* Installation of Holter implantable or
* Left auricular closure percutaneously Having formulated its non-opposition

Exclusion Criteria:

* Minor
* Patient's refusal
* Patients under legal protection

Primary outcomes:
measure: The occurrence of adverse clinical events
timeFrame: 5 years
Secondary outcomes:
measure: duration of intervention
timeFrame: Day 1
measure: dose of X-radiation used
timeFrame: Day1
measure: volume of used contrast agent
timeFrame: Day1
measure: duration of hospitalization
timeFrame: 3 months
measure: need for reoperation
timeFrame: 5 years
measure: evolution of the ECG
timeFrame: 5 years
measure: evolution of the echocardiographic parameters
timeFrame: 5 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: University Hospital, Brest
name: Jacques Mansourati, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891057: Sun Protection Factor Assay (SPF Assay 104/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT02837757: Everolimus Modulation of Anti-tumor T CD4 Immune Responses
Official title: Everolimus Modulation of Anti-tumor T CD4 Immune Responses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Renal Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma.

The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .


Eligibility criteria: Inclusion Criteria:

* Performance status ECOG-WHO 0, 1 or 2
* Metastatic renal cancer
* Patient candidate to everolimus treatment
* signed written informed consent
* fertile women with adequate contraception during the study and until 8 weeks after stopping treatment

Exclusion Criteria:

* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* History of immune deficiency
* Hypersensitivity against rapamycin and derived
* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
* Active autoimmune diseases, HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.

Primary outcomes:
measure: Change in regulatory T cell counts during treatment with everolimus
timeFrame: 9 months after everolimus initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
References:
Clinical trial NCT02936557: Sun Protection Factor Assay (SPF Assay 205/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT00791557: Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Official title: An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pyoderma Gangrenosum
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2008-11-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.

This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.


Eligibility criteria: Inclusion Criteria:

* Must Be ages 18-75
* Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum
* Must never have received Infliximab for the treatment of pyoderma gangrenosum

Exclusion Criteria:

* Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.
* Have a history of serious infections

Primary outcomes:
measure: The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
timeFrame: Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Neil J Korman, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: