louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02299843: RALPPS Venus ALPPS for Hepatocellular Carcinoma
Official title: A Prospective Randomized Controlled Trial of Radio-frequency Assisted ALPPS（RALPPS）and Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy（ALPPS）in the Treatment of Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: RFA
ALPPS
hepatectomy
morbidity and mortality
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently，the "ALPPS" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. However, the procedure has a high morbidity and mortality rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage I will reduce the incidence of complications（bile leakage, abdominal infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* An insufficient future liver remnant(FLR\<30% in normal hepatic function or FLR\<40% with hepatic cirrhosis or after chemotherapy）
* Liver function of Child-Pugh Class A or B.
* Liver Reserve Function：ICG-R15≤10％
* No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.

Exclusion Criteria:

* Patients met the inclusion criteria but declined to participate.
* Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
* Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus.
* Extrahepatic or lymph node metastasis

Primary outcomes:
measure: morbidity during perioperation
timeFrame: 2 years
measure: mortality during perioperation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Kuansheng Ma, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04560543: Prophylactic Laparoscopic Suspension After McCall
Official title: Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolapse Pelvic
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results.

The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.

Detailed description: 182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum.

Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.

Eligibility criteria: Inclusion criteria

* LSC simple hysterectomy,
* Neg. SS test if premenopausal
* \>18j,
* Consent to participate in the study
* Understanding of the German language

Exclusion criteria

* Prolapse as indication for surgery
* Known or suspected non-compliance
* Additional incontinence procedures
* Patients with deep infiltrating endometriosis
* Irradiation pre- or postoperative
* Pregnancy and lactation.
* Transgender population
* Conversion from laparoscopy to laparotomy
* Inability to understand the study protocol

Primary outcomes:
measure: Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm.
timeFrame: 5 years
Secondary outcomes:
measure: Sexual function
timeFrame: 5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsfrauenklink Inselspital
Study officials:
affiliation: Department of Gynaecology, University Hospital, Berne
name: Michel D Mueller, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03680443: Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement
Official title: Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement: A 62 Case Series at a Minimum 5 Years Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aseptic Loosening
Arthroplasty Complications
Keywords: revision
reinforcement
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Brief summary: Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up.

Detailed description: Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively. Dual-mobility cups have proved effective in preventing dislocation in THA revision for instability, but their behavior when cemented in a metal reinforcement has been little studied.

The present study assessed results for a dual-mobility cup cemented in a metal reinforcement, in terms of aseptic loosening and postoperative instability.

A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.

Eligibility criteria: Inclusion Criteria:

* patients between 19 and 84 years
* patients receiving such an assembly in THA revision

Exclusion Criteria:

* \<19years
* \> 94 years

Primary outcomes:
measure: dual-mobility cup cemented (effectiveness in terms of aseptic loosening)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Patrice Mertl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240743: Fixation Methods of Basicervical Fractures
Official title: Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Osteoporotic Fractures
Keywords: Basicervical
Cervicobasiler
Hip
Fracture
Prospective randomized
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-27
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.

Detailed description: Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.

Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.

Eligibility criteria: Inclusion Criteria:

* basicervical fracture,
* age of ≥65 year,
* an isolated fracture,
* the ability to walk independently (with or without an aid) prior to fracture,
* a fracture that had occurred less than one week prior to admission.

Exclusion Criteria:

* history of ipsilateral femoral fracture,
* a fracture due to malignancy,
* limited life expectancy due to medical comorbidities,
* any contraindication to surgery,
* diagnosed dementia,
* any other traumatic fracture on admission.

Primary outcomes:
measure: mobility score
timeFrame: 12 months
measure: Harris hip score
timeFrame: 12 months
measure: modified Barthel index
timeFrame: 12 months
measure: the tip-apex distance
timeFrame: 12 months
measure: fracture settling
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03126643: Expanded Access to Nivolumab (Opdivo)
Official title: Expanded Access to Nivolumab (Opdivo)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Pediatric Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-04-24
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD

Brief summary: At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.

When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.

Detailed description: Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join an early patient access program.

To learn more about early patient access programs, your doctor may contact BMS using the information provided below.

Eligibility criteria: Specific eligibility criteria must be met for access outside of a clinical trial.

These inclusion criteria include:

* The illness must be serious or life threatening
* There are no other viable options (including approved products or active clinical trials)
* There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
* Other defined inclusion/exclusion criteria could be applicable.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02575443: Neuromuscular Block and Anesthetic Depth Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 60
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: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).


Eligibility criteria: Inclusion Criteria:

* Gall bladder disease
* American Society of Anesthesiologist physical status 1 or 2

Exclusion Criteria:

* Pregnancy
* Body mass index \< 16
* Body mass index \>30
* Neuromuscular disease
* Previous intraabdominal surgery

Primary outcomes:
measure: Total infused dose of propofol
timeFrame: At 1 min after the anesthesia is finished
Secondary outcomes:
measure: Electromyographic index presented on the anesthetic depth monitoring system
timeFrame: Through study completion, an average of 2 hours
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: 82, Gumi 173
name: Hyo-Seok Na
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02793843: Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section
Official title: A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus
Cesarean Section
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 194
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus.

Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV).

Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.

Detailed description: A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status 1 and 2
* Scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria:

* Patients with cardiac and psychological problems
* Patients who take sedatives or narcotics
* Patient who have allergy to study drugs

Primary outcomes:
measure: Pruritus assessed through questionnaire
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Post operative nausea and vomiting assessed through questionnaire
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
References:
Clinical trial NCT04455243: Inflammatory Regulation Effect of NAC on COVID-19 Treatment
Official title: Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: NAC
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 1180
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: Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.


Eligibility criteria: Inclusion Criteria:

* Adult above 18 years of age
* Admitted to the hospital With confirmed COVID-19 by RT-PCR test
* On oxygen supplement

Exclusion Criteria:

* Active use of NAC
* Known NAC allergy
* In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
* All patients enrolled in any other investigational drug studies in COVID-19.

Primary outcomes:
measure: Time to Recovery
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00989443: Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
Official title: A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Cervical Neoplasms
Cervix Intraepithelial Neoplasia
Keywords: Cervix Intraepithelial Neoplasia grades 2 and 3
Lead sponsor: Mithra Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-05
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at :

1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.


Eligibility criteria: Inclusion Criteria:

* women aged between 18 and 50 years old
* volunteers
* informed consent signed
* cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
* no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion Criteria:

* pregnancy or breast feeding
* subtotal hysterectomy
* current or ancient renal impairment
* current immune disorder
* current use of drugs interfering with renal function
* current treatment for any cancer
* current use of treatment interfering with immunity
* current use of anti-viral treatment
* current or recent participation to another experimental study during the last 3 months before the screening visit
* current vaginal application of drugs or cosmetics
* local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Primary outcomes:
measure: adverse events
timeFrame: weeks 1, 2, 3 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme Hospital - Laboratoire de recherche en reproduction humaine
name: Michel Bossens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02214043: Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population
Official title: Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute pulmonary embolism in Chinese population

Brief summary: There are no special clinical characteristics of acute pulmonary embolism in Chinese population.


Eligibility criteria: Inclusion Criteria:

* the symptomatic acute PE confirmed by objective examination

Exclusion Criteria:

* congestive heart failure
* chronic obstructive pulmonary disease;
* a prior documented episode of PE or DVT
* renal dysfunction;
* a life expectancy of less than 6 months

Primary outcomes:
measure: The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.
timeFrame: 60 months
Secondary outcomes:
measure: The second end point was death (all cause death and PE-related death).
timeFrame: 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center of pumonary vascular diseases
Study officials:
affiliation: Chinese pulmonary vascular disease organization group
name: Zhihong Liu, Doctor
role: STUDY_CHAIR
References: