louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03355261: Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)
Official title: Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.

Detailed description: Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

Eligibility criteria: Inclusion Criteria:

* invasive ductal carcinoma diagnosed by biopsy;
* clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
* NAC regimen followed the NCCN guideline;
* no prior history of breast cancer or other malignancies.

Exclusion Criteria:

* the cycle number of neo-adjuvant chemotherapy is equal to or less than 2

Primary outcomes:
measure: The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location
timeFrame: During the surgery
Secondary outcomes:
measure: The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location
timeFrame: During the surgery
measure: The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location
timeFrame: During the surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: the First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Jianyi Li, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Jia S, Wang Y, Zhang Y, Kong L, Cao Y, Liu Y, Zhang Y, Chen B. Long-term tracing and staining of carbon nanoparticles for axillary lymph nodes in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy. Asian J Surg. 2022 Jan;45(1):89-96. doi: 10.1016/j.asjsur.2021.03.020. Epub 2021 Apr 27.
Clinical trial NCT01793961: Effects of Chronic Intake of Cannabis on Contrast Sensitivity
Official title: Effects of Chronic Intake of Cannabis on Contrast Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Dependence
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Rates of driving under the influence of cannabis have risen in recent years. Cannabis is involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. The investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be compared to standard references. In addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.

In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. The investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. The investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.


Eligibility criteria: Inclusion Criteria:

"Cannabis" Arm

* patient addicted to cannabis
* Positive CAST test result
* Urine tested positive for cannabis metabolites

"Tobacco" Arm

* positive Fagerström test result
* No cannabis intake in the last year before inclusion
* No previous history of cannabis use

"Healthy Volunteers"

* No tobacco or cannabis intake in the last year before inclusion
* No history of addictive disorders

Exclusion Criteria:

* addiction to other substances than cannabis or tobacco
* benzodiazepine treatment
* patient with history of benzodiazepine treatment
* patient with history of general anesthesia in the last 3 months before inclusion
* patient with history of head trauma
* Pregnant woman
* breast feeding woman
* Adults under supervision or guardianship

Primary outcomes:
measure: The contrast detection treshold
timeFrame: up to 9 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00994383: Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release
Official title: A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Comparative Bioavailability Study of Morphine Sulfate Immediate Release Tablets and Solution and Controlled Release Capsules Under Steady-State Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Characterize the steady-state pharmacokinetics of morphine after oral administration of Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of AVINZA.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick A Bieberdorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067883: Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients
Official title: Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis c
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, cohort, open label trial
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

Detailed description: The aim of this study is;

To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:

1. The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
2. To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

Eligibility criteria: Inclusion Criteria:

1. Under regular HD for at least 6 months
2. Clinically stable condition as outpatients.
3. Treatment naïve patients with serum positive for HCV GT4 with HCV RNA \> 1000 IU/ml by PCR.
4. White blood cell count \> 2500/mm\^3.
5. Platelet count \> 7500/mm\^3.
6. Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score \>3 \[including 3/4 or 3-4\] ).

Exclusion Criteria:

1. Confirmed pregnancy.
2. HCV-HIV co infection.
3. HBV-HCV co infection.
4. Uncontrolled hyper or hypothyroidism.
5. For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
6. Patients on peritoneal dialysis.

Primary outcomes:
measure: Sustained Virological Response
timeFrame: After 12 weeks after the last dose
Secondary outcomes:
measure: Treatment related withdrawal rate
timeFrame: during treatment period, average duration 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maadi armed forces hospital
state: Maadi
Study officials:
affiliation: Ain Shams University
name: Mai Mohamed Naguib Abd Elmen'em, B.pharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520883: Evaluation of Decisional Conflict and Needs Assessment in Asthma Management
Official title: Decisional Conflict and Needs Assessment in Shared Decision Making in Asthma Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
name: AllerGen NCE Inc.
First posted: 2012-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with mild to moderate asthma controlled or slightly controlled

Brief summary: Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.

Detailed description: Asthmatic patients will be recruited and asked to fill a decisional conflict scale.

Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.

Eligibility criteria: Inclusion Criteria:

* 18-65 years
* diagnosed asthma

Exclusion Criteria:

* received asthma education in the past 2 years

Primary outcomes:
measure: Measuring Decisional Conflict with a valid Decisional Conflict Scale
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Quebec
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232683: Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders
Official title: Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Urinary Retention
Keywords: Female Pelvic Floor Disorders
Postoperative Urinary Retention
Tamsulosin
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Detailed description: This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Eligibility criteria: Inclusion Criteria:

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.

ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion Criteria:

i. Diagnosis of urinary retention preoperatively (post void residual \>150ml)

ii. Malignancy

iii. History of neurological disease

iv. History of spinal cord injuries

v. Allergy to Tamsulosin

vi. Perioperative complications requiring prolonged postoperative bladder drainage

vii. Incontinence procedures other than mid-urethral slings

Primary outcomes:
measure: Tamsulosin Effect
timeFrame: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Secondary outcomes:
measure: Postoperative Narcotic Use
timeFrame: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
measure: Effect of Tamsulosin on postoperative blood pressure
timeFrame: Up to 4 hours after surgery while patient is in post-anesthesia care unit
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
References:
Clinical trial NCT02680483: Atrial Fibrillation Registry in Jordan
Official title: Atrial Fibrillation Registry in Jordan
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Registry
Middle East
Jordan
risk factors
in hospital management
long term management
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All new admissions with atrial fibrillation above the age of 18 or those who develop atrial fibrillation during hospitalization for non AF reason.

Brief summary: Prospective registry of all new comers with Atrial fibrillation

Detailed description: 12 tertiary care centers will enroll all AF comers. Details of baseline clinical, EKG, echo, and lab data will be documented for all patients. Management is according to the physicians discretion. Patients will be followed up for 1 year for clinical endpoints including cardiovascular death, stroke, heart failure, systemic embolization and bleeding.. Anticoagulants and other cardiovascular medications will also be documented.

Eligibility criteria: Inclusion Criteria:

* Admission with atrial fibrillation
* developing atrial fibrillation during hospitalization for mon AF reason.
* age 18 or more years.
* patients welling to participate in the registry.

Exclusion Criteria:

* age less than 18 years.
* patients not welling to participate.

Primary outcomes:
measure: Incidence of stroke and systemic embolization and cardiovascular death
timeFrame: 1 year
Secondary outcomes:
measure: Number of readmission for atrial fibrillation
timeFrame: 1 year
measure: Number of readmission for other cardiovascular events
timeFrame: 1 year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari hospital
Study officials:
affiliation: Istishari Hospital
name: Munir Zaqqa, MD FACC
role: STUDY_DIRECTOR
References:
Clinical trial NCT02941783: Drug Use Investigation of Kovaltry in Hemophilia A Patients
Official title: Drug Use Investigation of Kovaltry in Hemophilia A Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hemophilia A
Keywords: Kovaltry
hemophilia A
Japan
Post-marketing surveillance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.

Brief summary: The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.

Detailed description: This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.

Eligibility criteria: Inclusion Criteria:

* Male and female hemophilia A patients.
* Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A

Primary outcomes:
measure: Number of participants with adverse events as measure of safety and tolerability
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events as measure of safety and tolerability
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of annual bleeds
timeFrame: Up to 2 years
measure: Efficacy of controlling of bleeds
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03919383: Phase II of Lenvatinib Plus Toripalimab for Advanced HCC
Official title: Phase II of Lenvatinib Plus Toripalimab Advanced Hepatocellular Carcinoma: a Single-arm Prospective Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Lenvatinib
Toripalimab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 0
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: The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with toripalimab in patients with advanced hepatocellular carcinoma (HCC)

Detailed description: Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus toripalimab. Thus, the investigators carried out this single-arm, prospective, phase II study to find out it.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous systemic treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: 6 months progression free survival rates
timeFrame: 6 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: 6 months
measure: Objective Response Rate (ORR)
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References: