louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00497354: Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?
Official title: Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain After Shoulder Surgery
Keywords: Ultrasound, Complications, Regional Anesthesia
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Peripheral nerve blocks provide many advantages for patients (excellent pain control and reduction in nausea) undergoing upper and lower limb surgery however several commonly occurring complications can produce annoying but sometimes serious adverse effects. The interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of these side effects limits the use of ISBPB in many patients who would particularly benefit e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing practitioners to place smaller volumes of local anesthetic with much greater accuracy. This can potentially avoid anesthetizing important adjacent nerves to the target structure. If ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated to reduce the incidence of complications without reducing effectiveness this would be very beneficial for patients.This will be the first randomized, double blind study to evaluate if an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and postoperative period.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective shoulder surgery.
* Patients aged \>=18 and \<=70 years
* ASA I-III
* BMI\<35

Exclusion Criteria:

* Preexisting COPD
* Unstable asthma
* Psychiatric history
* Allergy to ropivacaine.
* Opioid tolerance (\>30mg oral morphine or equivalent/day)

Primary outcomes:
measure: Diaphragmatic paresis
timeFrame: 30 minutes post block insertion
Secondary outcomes:
measure: Analgesic efficacy
timeFrame: 30,60,90,120 minutes post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Colin JL McCartney, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071054: Continuous 7-day Detection of Arrhythmias in Dialysis Population
Official title: Optimized Continuous 7-day Detection of Arrhythmias in Dialysis Population by a Patch With a High Resolution Differentiation of Atrial Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arrythmia
Dialysis; Complications
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodialysis patients with a chronic hemodialysis program

Brief summary: The Carnation Ambulatory Monitor (CAM) is an innovative diagnostic patch device that allows to differentiate the different kinds of arrhythmias more precisely than any other ECG-monitoring device. It attaches on the sternum and can be carried for a week without any breaks. This allows a continuous rhythm monitoring without any gap for 7 days.

This device will be used in dialysis patients to monitor arrhythmias during changes in volume and/or electrolyte balance due to dialysis, in the phases after dialysis as well as before dialysis in the short or long intervals between dialysis sessions.


Eligibility criteria: Inclusion Criteria:

* Age 18 years.
* Written informed consent

Exclusion Criteria:

* Participation in another study within 4 weeks before study begin
* Pacemaker
* ICD

Primary outcomes:
measure: Number of dialysis patients with an arrhythmia
timeFrame: ECG monitoring over 7 days (3 intermittent hemodialysis sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Study officials:
References:
Clinical trial NCT00476554: A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Official title: A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cutaneous T-cell Lymphoma (CTCL)
Keywords: CTCL
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).

Detailed description: This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Eligibility criteria: Inclusion Criteria:

* Adult patients with advanced CTCL
* Have had at least 2 systemic therapies
* Must have evaluable disease
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate bone marrow, hepatic and renal function
* At least 3 weeks from prior therapies
* Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
* Able to swallow capsules
* At least 3 weeks from major surgery
* Agree to practice effective contraception
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Receiving systemic steroids
* Receiving topical or systemic retinoids or vitamin A
* Receiving radiotherapy, biological therapy,or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Active hepatitis B and/or hepatitis C infection

Primary outcomes:
measure: response rate in overall skin disease
timeFrame: over the course of study
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
city: Chicago
country: United States
facility: Timothy Kuzel, M.D.
state: Illinois
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cyclacel Pharmaceuticals, Inc.
name: Judy H Chiao, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04327154: TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
Official title: A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Nerve Injury
Keywords: nerve repair
digital nerve repair
digital nerve lesion
peripheral nerve injury
peripheral nerve lesion
peripheral nerve repair
Lead sponsor: Tissium
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing a repair of a proper digital nerve of the hand;
* 100% transection injury to the nerve under repair;
* Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
* Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
* Patient willing and able to provide a signed Patient Informed Consent Form;
* Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.

Exclusion Criteria:

* Patient has a known allergy to the constituent polymer of the investigational device;
* Patient has a documented diagnosis of peripheral neuropathy;
* Patient has a history of neuropathic pain;
* Patient has a history of injury to the nerve being studied;
* Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
* Patient is pregnant or nursing
* Any patient with a diagnosis of type 1 Diabetes Mellitus;

Primary outcomes:
measure: Cumulative incidence of complications (CIC) related to the investigational device
timeFrame: through 12-months post-procedure
Secondary outcomes:
measure: Semmes-Weinstein monofilament (SWMF) for nerve functional recovery
timeFrame: at 6 months post-procedure
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast University Hospital
state: Queensland
Study officials:
affiliation: Gold Coast University Hospital
name: Randipsingh Bindra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05146154: Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Official title: Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Critical Illness
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years of age
2. Admitted to the ICU
3. BMI ≥40 kg/m2 and/or total body weight ≥120 kg
4. Provide a signed and dated written informed consent prior to study participation

Exclusion Criteria:

1. History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
2. History of seizures and/or receiving 1 or more anti-epileptic agent
3. Serum creatinine ≥1.5 mg/dL
4. Estimated creatinine clearance (CLCR) \<60 mL/minute as determined by Cockcroft-Gault equation:
5. Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
6. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication
7. Positive serum pregnancy test (for women of childbearing potential)
8. Currently breast feeding
9. Has previously participated in this study
10. Concomitant use of valproic acid or divalproex sodium
11. Any other condition that may make the patient unsuitable for the study in the judgement of the investigator

Primary outcomes:
measure: Pharmacokinetic parameters of imipenem and relebactam
timeFrame: 6 months
measure: Pharmacokinetic parameters of imipenem and relebactam
timeFrame: 6 months
measure: Pharmacokinetic parameters of imipenem and relebactam
timeFrame: 6 months
measure: Pharmacokinetic parameters of imipenem and relebactam
timeFrame: 6 months
Secondary outcomes:
measure: Safety of imipenem and relebactam
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT00871754: Molecular Analysis Of Bladder Cancer
Official title: Molecular Analysis Of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Bladder Neoplasms
Keywords: Bladder Cancer
Cancer, bladder
Urinary Bladder Cancer
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient's undergoing removal of a malignant bladder tumor

Brief summary: This is a laboratory study where the investigators hope to look at chromosomal events implicated in bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Bladder cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Kim Reiger-Christ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05610254: The Cold Fluids Study
Official title: Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: University of Southern Denmark
name: Simon Fougner Hartmanns Family Foundation
name: Department of Clinical Biochemistry, Vejle Hospital
First posted: 2022-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index \>35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.

Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Primary outcome is

* The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
* Time until return of MAP to baseline value after infusion.


Eligibility criteria: Inclusion Criteria:

* Age between 18-64

Exclusion Criteria:

* Pre-existing medical problems
* Pregnancy (validated through a certified pregnancy test)
* Body mass index \>35 kg/m2
* Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.

Primary outcomes:
measure: Increase in MAP at 15 minutes after infusion of the fluid bolus.
timeFrame: 15 minutes
Secondary outcomes:
measure: Time until return of MAP to baseline value after infusion.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT05780554: Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
Official title: Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graft Vs Host Disease
Lead sponsor: Centro de Hematología y Medicina Interna
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood.

In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.


Eligibility criteria: Inclusion Criteria:

* Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases).
* Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver.

Exclusion Criteria:

* Patients who refuse to sign the consent form.
* Latent infection.
* Hepatic, cardiac or bronchopulmonary symptomatic diseases
* Abnormalities on previous clinical hematological appointments, considered as contraindication.
* Positive serology for HIV, VHB, VHC

Primary outcomes:
measure: Acute GVHD rate
timeFrame: 6 months
measure: Chronic GVHD rate
timeFrame: 18 months
measure: Relapse free survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Centro de Hematología y Medicina Interna
Study officials:
References:
Clinical trial NCT00226954: Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
Official title: Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urologic Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-27
Enrollment: 23
Sex: MALE
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: Primary:

To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Secondary Objectives:

To describe the safety and tolerability at this dose and schedule


Eligibility criteria: Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine \>2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits

Primary outcomes:
measure: To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Secondary outcomes:
measure: To describe the safety and tolerability at this dose and schedule
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References: