louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02597257: Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain
Official title: Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Diabetic Polyneuropathy
Peripheral Neuropathy
Keywords: Lidocaine infusion therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2015-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.

Detailed description: The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.

Eligibility criteria: Inclusion Criteria:

* postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
* NRS score \> 4
* stable oral medication during the 1 month trial period
* volunteers with informed consent

Exclusion Criteria:

* pregnancy, breastfeeding, possibility of pregnancy
* pain from causes other than upper 3 indications
* hypersensitivity to lidocaine or other local anesthetics
* important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study
* severe conduction block
* history of other interventions that may affect the study
* Enrollment in other clinical trials within 30 days
* otherwise not suitable to study

Primary outcomes:
measure: 11-point Numeric Rating Scale
timeFrame: 1 week after the end of intervention
Secondary outcomes:
measure: Brief Pain Inventory Short Form
timeFrame: at the end of intervention and 4 weeks after the end of intervention
measure: Shot Form McGill Pain Questionnaire
timeFrame: at the end of intervention and 4 weeks after the end of intervention
measure: Patient Global Impression of Change
timeFrame: at the end of intervention and 4 weeks after the end of intervention
measure: Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 4.0
timeFrame: through the study completion (7 weeks)
measure: 11-point Numeric Rating Scale
timeFrame: 4 weeks after the end of intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yong Chul Kim
Study officials:
affiliation: Seoul National University Hospital
name: Yong Chul Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.
Clinical trial NCT02339857: The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.
Official title: The Long-term Results of Coronary Artery Bypass Surgery When the No-touch Vein Graft is Anastomised to the Left Anterior Descending Artery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Atherosclerosis
Keywords: coronary artery bypass grafting
saphenous vein
grafts
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2015-01-16
Enrollment: 97
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: All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.

Brief summary: The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.


Eligibility criteria: Inclusion Criteria:

1. Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
2. Saphenous vein graft harvesting using the no-touch technique.
3. The saphenous vein anastomised to the left anterior descending artery.
4. Informed consent

Exclusion Criteria:

1. Allergy to contrast media.
2. Impaired renal function.
3. Inability to conduct the study according to protocol.

Primary outcomes:
measure: Total patency of the no-touch vein grafts.
timeFrame: Mean time 8 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine and Health, Örebro University, Örebro, Sweden
name: Ninos Samano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04353557: ctDNA Monitoring in Early Breast Cancer
Official title: Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: ctDNA
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Army Medical University, China
First posted: 2020-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-III breast cancer who planed to receive curative-intent treatment.

Brief summary: This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 80 years old
2. Histologically proven primary breast cancer with clinical stage I-III
3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
4. Expected to achieve R0 resection.
5. Estimated lifetime is more than 3 months.
6. Signed Informed Consent Form
7. Consent to provide research blood samples.

Exclusion Criteria:

1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

Primary outcomes:
measure: Positive ctDNA detection at first post-operative timepoint
timeFrame: 1 month post-surgery
Secondary outcomes:
measure: Positive ctDNA detection at post-operative timepoints
timeFrame: 6/12/18/24/30 months
measure: Association between ctDNA detection and time to recurrence
timeFrame: 1 month post-surgery
measure: Association between ctDNA detection and time to recurrence
timeFrame: 6/12/18/24/30 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Army Medical Center of PLA, China
state: Chongqing
Study officials:
References:
Clinical trial NCT02061657: Impact of Misoprostol on Blood Loss In Myomectomy Operations
Official title: Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leiomyoma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

Detailed description: This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.

A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.

The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Eligibility criteria: Inclusion Criteria:

* Premenopausal patients aged between 35 to 50 years old.
* Five or less symptomatic uterine myomas .
* Maximum diameter of the largest myoma is 6 cm .
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* History of previous surgery.
* Allergy to Misoprostol.
* Hypertension.
* Cardiac and Pulmonary diseases.
* Patients who have bleeding disorders.
* Anemia (Hb \< 10g %).
* Chronic endocrine or metabolic diseases such as Diabetes.
* Obesity (body mass index \> 30 kg/m2).
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Primary outcomes:
measure: intraoperative blood loss
timeFrame: time from peritoneum opening till its closure around (1 Hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Abd El Mgeed I. Abd El Mgeed, Professor
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Mohamed S. Ali, Professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Mohamed A. Abdel-Hafeez, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Mina A. Yacoup, Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Ahmed M. Elnaggar, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.
Clinical trial NCT04165057: Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy
Official title: Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Laparoscopic surgery
Optimal muscle tension
Neuromuscular monitoring
Neuromuscular blockade
Sugammadex
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.

Detailed description: This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.

Eligibility criteria: Inclusion Criteria:

* age 20\~80 years old
* ASA score : 1-2
* Regular laparoscopic cholecystectomy

Exclusion Criteria:

* Renal function impairement (eGFR \< 60 ml/min/1.73m2) or ESRD
* BMI \< 18.5 kg/m2 or \>30 kg/m2
* History of other abdominal surgery
* Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
* Emergent surgery
* Convert to open cholecystectomy

Primary outcomes:
measure: Surgical condition
timeFrame: 5 minutes
Secondary outcomes:
measure: Peak inspiratory pressure during surgery
timeFrame: 1 hour
measure: Mean blood pressure
timeFrame: Every 5 mins
measure: Total surgical time
timeFrame: 1 hour
measure: Total Rocuronium doses during surgery
timeFrame: 1 hour
measure: Pain score at Postoperative room
timeFrame: 1 hour
measure: Heart Rate
timeFrame: every 5 mins
measure: Respiratory complications
timeFrame: Every 5 mins
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Hsin-Chu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsinchu Branch
name: MING-HUI HUNG, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02771457: Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Official title: Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Keywords: Influximab
IFX
Remicade
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 0
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: The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 years or older who are willing and able to provide informed consent
* HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
* History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
* Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
* Infliximab drug holiday for at least 12 weeks.

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Pregnant patients
* Prior history of serious infusion reaction to IFX

Primary outcomes:
measure: Failure Rate
timeFrame: One year
Secondary outcomes:
measure: Short-term clinical response
timeFrame: One year
measure: Long-term clinical response
timeFrame: One year
measure: Short-term changes in patient Quality of Life
timeFrame: One Year
measure: Long-term changes in patient Quality of Life
timeFrame: One Year
measure: Fecal calprotectin measurements
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Lea Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773357: Modeling Stress-precipitated Smoking Behavior for Medication Development
Official title: Modeling Stress-precipitated Smoking Behavior for Medication Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking lapse behavior
guanfacine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Office of Research on Women's Health (ORWH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.


Eligibility criteria: Inclusion Criteria:

* ages 18-60
* able to read and write in English
* smokers

Exclusion Criteria:

* any significant current medical conditions that would contraindicate smoking
* current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal or evidence of severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* participants who have engaged in a quit attempt in the past 3 months
* specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>450 msec for men and QTc\>470 msec for women; known intolerance for guanfacine

Primary outcomes:
measure: Latency to Initiate Ad-lib Smoking Session
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00435357: Comparison Between Fixed- Versus Mobile-bearing TKA
Official title: Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthritis
Keywords: Mobile-bearing
arthroplasty
fixed-bearing
knee
patella
posterior stabilized TKA
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.


Eligibility criteria: Inclusion Criteria:

* Medial medial femorotibial arthritis requiring an arthroplasty
* Age between 50y and 90y

Exclusion Criteria:

* Lateral femorotibial arthritis
* Inflammatory disease
* Stiff knee with flexion under 90°
* Revision TKA
* Previous surgery (except meniscectomy)

Primary outcomes:
measure: International Knee Society Score
timeFrame: 2, 6 and 12 monthes after surgery
Secondary outcomes:
measure: Patellofemoral tilt on skyline view, measurement of two angles :
timeFrame: 2 and 12 monthes after surgery
measure: patellar tilt
timeFrame: 2 and 12 monthes after surgery
measure: patellar displacement from the center of the trochlear groove
timeFrame: 2 and 12 monthes after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Sebastien Lustig
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe Neyret, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837057: Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury
Official title: A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Sepsis
Septic Shock
Acute Kidney Injury
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.

The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.


Eligibility criteria: Inclusion Criteria:

* Septic shock (Bone criteria) for less than 14D
* RIFLE criteria : Injury or Failure or nearly anuria more than 2hr
* Age over 18 years
* Written informed consent by next of kin.

Exclusion Criteria:

* Cirrhosis child class C
* CRF or ESRD
* Too high APACHE II \& SOFA score at admission
* Age over 80 years
* Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)

Primary outcomes:
measure: Death from all causes at 28 days after randomisation
timeFrame: 28 day
Secondary outcomes:
measure: Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support
timeFrame: 90 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: