louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01646801: Study of NMB Drug Ejecting Balloon for Peripheral Arteries
Official title: The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: N.M.B. Medical Applications Ltd
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 20
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 demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or older
* Patient with lifestyle limiting claudication or rest pain (Rutherford- Becker scale 2, 3 or 4).
* Patient with de novo lesion or restenotic lesion ≥70% in the iliac, femoral, popliteal or tibial artery.
* The target lesion can be successfully crossed with a guide wire and dilated.
* The target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in length.
* Patient is willing to and able to sign a written informed consent and to comply with procedures (e.g., adherence to follow-up visits, including 6 months CT-angiography/MRA follow-up).

Exclusion Criteria:

* Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
* Previous participation in another study with any investigational drug or device within the past 30 days.
* The patient is currently enrolled in another investigational device or drug trial.
* Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
* Stenosis with corresponding thrombosis treated within 7 days before enrollment.
* Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
* Patient that has co-morbid illness that may result in life expectancy of less than 12 months.
* History of haemorrhagic stroke or gastro-intestinal bleeding within 6 months.
* Patient with major surgery during the 30 days preceding the interventional procedure.

Primary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: 6 months
Secondary outcomes:
measure: Restenosis rate
timeFrame: 6 months
measure: Device Malfunction
timeFrame: intraprocedural, 3, 6 and 12 months
measure: Adverse events
timeFrame: intraprocedural, 3, 6 and 12 months
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: The Rabin Medical Center, Hasharon Hospital
Study officials:
References:
Clinical trial NCT06900101: Multimodal Monitoring Study in Neuro Critical Care
Official title: Multimodal Monitoring Study in Neuro Critical Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subarachnoidal Hemorrhage
Intacranial Hypertension
Acute Trauma Brain Injury
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in neuro critical care, in Pierre Wertheimer hospital, for acute brain injury and monitored by MOBERG® system.

Brief summary: During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders.

Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS).

Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.


Eligibility criteria: Inclusion Criteria:

* - Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
* Monitored with the CNS MOBERG® monitoring system

Exclusion Criteria:

* - Refusal to participate
* Patients under legal protection

Primary outcomes:
measure: Correlation between ORx and PRx
timeFrame: Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Hopital Pierre Wertheimer
state: Bron
Study officials:
References:
Clinical trial NCT00127101: An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)
Official title: A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat; Zolinza) in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 23
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: This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.


Eligibility criteria: Inclusion Criteria:

* Women or men greater than or equal to 18 years of age
* Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease
* Failure of at least one systemic therapy, not including Bexarotene (Targretin)
* Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)

Exclusion Criteria:

* Patient has had investigational treatment in the preceding 30 days
* Active hepatitis B or C, history of HIV
* Prior treatment with any HDAC inhibitor
* Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
timeFrame: Day 1 to day 28
Secondary outcomes:
measure: Number of Participants Who Responded to Treatment
timeFrame: Every 28 days for up to 6 Months of Treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Dummer R, Beyer M, Hymes K, Epping MT, Bernards R, Steinhoff M, Sterry W, Kerl H, Heath K, Ahern JD, Hardwick JS, Garcia-Vargas J, Baumann K, Rizvi S, Frankel SR, Whittaker SJ, Assaf C. Vorinostat combined with bexarotene for treatment of cutaneous T-cell lymphoma: in vitro and phase I clinical evidence supporting augmentation of retinoic acid receptor/retinoid X receptor activation by histone deacetylase inhibition. Leuk Lymphoma. 2012 Aug;53(8):1501-8. doi: 10.3109/10428194.2012.656625. Epub 2012 Feb 13.
Clinical trial NCT04236401: Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions
Official title: Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electrosurgery Versus Scalpel
Keywords: electrosurgery
scalpel
abdominal incision
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 90
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: SUPPORTIVE_CARE

Brief summary: the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

Detailed description: • Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.

Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.

Participants at morning of the operation will be given information about the study aims and written consent will be taken.

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for elective gynecological abdominal surgeries for benign diseases
* willing to participate in the study.
* The participants will receive 2 gm cephalosporines preoperative per hospital policy.

Exclusion Criteria:

* History of receiving antibiotics during the preceding 7 days,
* chronic medical illness like diabetes, asthma or tuberculosis,
* patients have anemia,
* surgically scarred tissues,
* Immuno-compromised patients,
* pregnant patients,
* patients with pacemaker device,
* patients on anticoagulants therapy

Primary outcomes:
measure: Wound incision time
timeFrame: at the beginning of each surgery
measure: Wound infection
timeFrame: after surgery till primary healing of the wound, an average of 15 days after operation
Secondary outcomes:
measure: Postoperative pain (pain score 2-4 hr postoperative).
timeFrame: during first 4 hours after surgery
measure: Amount of Analgesia needed during 1st 12 hr after surgery .
timeFrame: first 12 hours after surgery
measure: Wound-related blood loss
timeFrame: after opening anterior abdominal wall during each surgery
measure: number of participants with bad scar formation or keloid
timeFrame: through study completion, an average of 1.25 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04466501: ACR | LAB Urine Analysis Test System Evaluation of Performance
Official title: A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm.

The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.


Eligibility criteria: Inclusion Criteria:

* Men and women 18-80 years of age;
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  * Diabetes Type I/Type II,
  * Hypertension,
  * Any kidney disease,
  * Other relevant conditions.
* Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);
* Subject is capable and willing to provide informed consent;
* Subject has facility with both hands
* Subject is capable and willing to adhere to the study procedures.

Primary outcomes:
measure: Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Garden City
country: United States
facility: AccuMed research associates
state: New York
Study officials:
References:
Clinical trial NCT05722301: Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Official title: Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: American Hip Institute
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement. Subjects will be male patients \> 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease. All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo. A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects. Testosterone therapy will be administered once to each patient at 2 weeks before surgery. The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.


Eligibility criteria: Inclusion Criteria:

* Male patients
* 50 years of age and older
* Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.

Exclusion Criteria:

* History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer free
* History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
* History of deep vein thrombosis (DVT)
* Presence of Factor V Leiden (as seen in labs)
* Presence of Protein S Deficiency (as seen in labs)
* History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
* Liver disease (as viewed by liver function tests)
* Testosterone free level greater than 10pg/mL
* Hematocrit \>51%; PSA \>= 3ng/mL.

Primary outcomes:
measure: Harris Hip Score
timeFrame: 3 months
measure: Harris Hip Score
timeFrame: 1 year
measure: Forgotten Joint Score
timeFrame: 3 months
measure: Forgotten Joint Score
timeFrame: 1 year
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 3 months
measure: Visual Analog Scale
timeFrame: 1 year
measure: Patient Satisfaction (reported from questionnaire)
timeFrame: 3 months
measure: Patient Satisfaction (reported from questionnaire)
timeFrame: 1 year
Other outcomes:
Locations:
city: Des Plaines
country: United States
facility: American Hip Institute Research Foundation
state: Illinois
Study officials:
References:
Clinical trial NCT03370601: Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases
Official title: Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: crohn's disease
ulcerative colitis
infliximab
loss of response
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
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 evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.


Eligibility criteria: Inclusion Criteria:

* patients with ulcerative colitis or crohn's disease
* treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
* active disease ( HBI \> 5 for CD patients or SCCAI\> 6 for UC patients)
* patients treated with infliximab only at the time of loss of response

Exclusion Criteria:

* Patients with CD with ano perineal lesions and without luminal activity
* patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
* patients with acute severe flare (HBI\>12 for CD patients and Lichtiger score \> 10 for UC patients)
* pregnant female
* patients with anal disease alone

Primary outcomes:
measure: Number of patients in Clinical remission
timeFrame: At Week 52
Secondary outcomes:
measure: Number of patients in deep remission
timeFrame: At Week 52
measure: Number of patient in remission and clinical response
timeFrame: At week 16
measure: infliximab blood concentration
timeFrame: Baseline, week 16 ad week 52
measure: infliximab antibodies concentration
timeFrame: Baseline, week 16 ad week 52
measure: economic criteria
timeFrame: At week 52
measure: number of patient with adverse effects and allergic reactions with infliximab
timeFrame: At week 52
measure: Inflammatory bowel disease questionnaire (score IBDQ)
timeFrame: Baseline and week 52
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Benjamin Pariente, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06510101: Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones: A Case Series
Official title: Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones: A Case Series
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Manual Manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys With Renal Stones:a New Method by
Keywords: organ donation;
kidney transplantation
flexible ureteroscopy;
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Third People's Hospital
name: The University of Hong Kong-Shenzhen Hospital
First posted: 2024-07-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patinet in our centor get a ranal transplantation with stones

Brief summary: we report the manual manipulation and Ex Vivo Flexible Ureteroscopic Lithotripsy to Salvage Deceased Donor Kidneys with Renal Stones,including nine cases,Renal transplantation was performed with the treated kidney after removing the stones, and the short-term postoperative outcomes were promising. cases were thoroughly reported in this paper.

Detailed description: The presence of donor kidney stones may lead to ureteral obstruction after transplantation, affecting the recovery of postoperative renal function. Thus, donors with kidney stones are often considered marginal kidney donors and likely disqualified,Here we describe a series case of multiple kidney stones in a donor kidney treated with the combined application of fURS and holmium laser lithotripsy (HLL) before transplantation. Renal transplantation was performed with the treated kidney after removing the stones, and the short-term postoperative outcomes were promising. The case was thoroughly reported in this paper.

Eligibility criteria: Inclusion Criteria:

* get renal transplantation donor kidney with stones

Exclusion Criteria:

* without renal stones the renal stones without Ex Vivo Flexible Ureteroscopic Lithotripsy

Primary outcomes:
measure: eGFR
timeFrame: 3monthes after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: yingxin Fu
state: Guangdong
Study officials:
References:
Clinical trial NCT04996901: The Chinese STEMI PPCI Registry (CSPR)
Official title: The Chinese ST-Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: The First College of Clinical Medical Science, China Three Gorges University
name: The First Affiliated Hospital of Dalian Medical University
name: Jiangxi Provincial People's Hopital
name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Xiangyang No.1 People's Hospital
name: Wuhan Third Hospital
First posted: 2021-08-09
Enrollment: 5594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with STEMI were treated by primary percutaneous coronary intervention at 7 large centers from central China.

Brief summary: The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.

Detailed description: The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.

Eligibility criteria: Inclusion Criteria:

1. Age≥18
2. ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction
3. STEMI treated by pPCI

Exclusion Criteria:

1. Patient with heart failure in admission
2. STEMI with symptom-onset-to-balloon time\>24h
3. pPCI was not successful or only underwent coronary angiography
4. Killip class ≥II in admission

Primary outcomes:
measure: in-hospital acute de novo heart failure
timeFrame: in-hospital outcome, until discharge
measure: cardiogenic shock
timeFrame: in-hospital outcome, until discharge
measure: death
timeFrame: in-hospital outcome, until discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan university
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Liwei Cheng
role: STUDY_DIRECTOR
References: