louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06581315: Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Official title: Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Adjuvant Therapy
Keywords: Hepatocellular Carcinoma
Adjuvant Therapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.


Eligibility criteria: Inclusion Criteria:

* Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
* High Risk of recurrence as assessed by tumor characteristics
* Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
* Child-Pugh Class A statu
* ECOG Performance Status of 0 or 1
* CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
* Expected survival time of no less than 3 months

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Evidence of residual or a history of spontaneous tumor rupture
* Recurrent HCC
* Prior received Liver transplantation
* Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
* AFP does not return to normal 4 weeks after operation

Primary outcomes:
measure: One year recurrence-free survival (RFS) rate
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence-Free Survival (RFS )
timeFrame: 6 years
measure: Recurrence-Free Survival rate (RFS rate)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 6 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Changzhen Shang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02984215: aCGH Impacts Survival in Plasma Cell PTLD
Official title: Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-transplantation Lymphoproliferative Disorders
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We conducted a retrospective analysis between 1990 and 2012 of all consecutive cases of PCM and PLL-PTLD collected in the Centre Hospitalier Lyon Sud (CHLS, 6 cases) and in Necker - Enfants Malades Hospital in Paris (4 cases). There were 4 females and 6 males. Among the 8 adults, 6 had received a kidney transplant, 1 a heart transplant and one a lung transplant. Among the 2 children, one had received a heart transplant and one an allogeneic stem cell transplantation with a matched unrelated donor. Immunosuppressive regimens were heterogeneous.

Brief summary: Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.


Eligibility criteria: Inclusion Criteria:

* WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders).

Exclusion Criteria:

* Other than PCM or PLL PTLD at diagnosis

Primary outcomes:
measure: Genome wide array-based comparative genomic hybridization (aCGH)
timeFrame: At diagnosis of PTLD, Day 0.
Secondary outcomes:
measure: Overall survival according to aCGH complexity
timeFrame: Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre hospitalier Lyon sud
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT00199615: Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC
Official title: Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: lung cancer, 18 FDG, PET
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent resection for NSCLC
* Informed consent

Exclusion Criteria:

* Patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells.
* Patients with non-resected NSCLC or with metastasis
* Patients who have previous malignancy, except basal cell carcinoma of the skin -

Primary outcomes:
measure: Disease-free survival from the date of operation to the date of recurrence or censured at the date of last follow-up visit or date of the death.
Secondary outcomes:
measure: - Overall survival from the date of the operation to the death
measure: - Specificity, sensibility and accuracy of TEP to detect recurrence
measure: - Direct cost of follow-up from the Frenc Healthcare insurance
Other outcomes:
Locations:
city: Limoges
country: France
facility: Pathologie Respiratoire
Study officials:
affiliation: University Hospital, Limoges
name: Boris MELLONI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04375215: Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions
Official title: Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical study
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.

Detailed description: The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.

Eligibility criteria: Inclusion Criteria:

* Outpatient in age range of 18yr-60yr
* Permanent mandibular posterior teeth with deep caries
* Caries extending to \>3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
* Positive response to cold test and electric pulp test

Exclusion Criteria:

* Any general disease affecting the caries e.g. patient under head and neck radiotherapy
* Patients with immuno-compromised status
* Tooth with fracture line, cracks.

Primary outcomes:
measure: Clinical success
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Radiographic Success
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Science
state: Haryana
Study officials:
References:
Clinical trial NCT05137015: Preventing Injuries in Young Football Players
Official title: Preventing Injuries in Young Football Players: a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Prevention
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 1027
Sex: MALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised controlled trial
Primary purpose: PREVENTION

Brief summary: Football is the most popular sport in the world, with 260 million male and female active participants, including \~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Studies on elite and non-elite footballers have reported similar injury rates in both genders. The most common football-related injuries are the knee and ankle ligament and thigh muscle strains, Over the past two decades, significant advancement has been made in the field of injury prevention in football. There are used trials to prevent specific injuries, as ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created programs designed to prevent a wider spectrum of injuries like FIFA11+.

Therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.


Eligibility criteria: Inclusion Criteria:

officially registered football club in the football federation of Kosovo players must be between 13-19 years old regular training must take place at least three times per week

Exclusion Criteria:

teams already using an injury prevention program injured players

Primary outcomes:
measure: Overall injury rate
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gjakove
country: Kosovo
facility: University of Gjakova
Study officials:
References:
Clinical trial NCT01745315: Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy
Official title: Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative Outcomes
Keywords: total laparoscopic hysterectomy
LigaSure
EnSeal
Halo PKS Cutting forceps
electrothermal bipolar vessel sealer
advanced bipolar device
Lead sponsor: Adana Numune Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-12-10
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the present study is to compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative complications, return of gastrointestinal activity and hospitalization time.


Eligibility criteria: Inclusion Criteria:

* any women with the indication of hysterectomy

Exclusion Criteria:

* malignancy
* having 3 or more previous abdominal surgeries
* uterus being larger than 12 weeks of gestation
* patients who must undergo additional surgical procedures during the same operation

Primary outcomes:
measure: Perioperative Outcomes
timeFrame: Until 45 patients are operated (6 months anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Numune Training and Research Hospital
Study officials:
affiliation: Adana Numune Training and Research Hospital
name: Hakan Aytan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01612585: Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China
Official title: A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Coronary Heart Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2012-06-06
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 30 hospitals

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.

Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals

Data will be collected in three aspects by three different forms as following:

Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form

Eligibility criteria: Inclusion Criteria:

* Patients using Dengzhanxixin injection from 2012 to 2014

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction.
timeFrame: The registry procedure will last 3 years only for patients using Dengzhanxixin
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03887585: Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
Official title: Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achilles Tendon Contracture
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.

Detailed description: This study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. In this study, Achilles tendon parenchymal at distal level is hemisected through the most distal incision, Achilles tendon parenchymal at proximal level is hemisected through the middle incision, then Achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. It can better achieve soft tissue balance and reduce the recurrence of Achilles tendon contracture when Achilles tendon strength in plantarflexion is weakened. Thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken Achilles tendon strength in plantarflexion.

Eligibility criteria: Inclusion Criteria:

* Patients older than three years old;
* Severe Achilles tendon contracture and equinus;
* The time after Achilles tendon contracture more than 6 months ;
* Initial Achilles tendon lengthening.

Exclusion Criteria:

* Patients younger than 3 years;
* The course of Achilles tendon contracture is within 6 months;
* Patients who have suffered from the Achilles tendon lengthening;
* Obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf;
* Osteotomy or tendon transposition is needed.
* Ankle joint is damaged obviously, such as Charcot's joint or Hemophilic arthritis;
* Skin soft-tissue infection in the lower limb.
* Initial Achilles tendon lengthening.

Primary outcomes:
measure: Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
timeFrame: Before surgery and up to 8 years after surgery
Secondary outcomes:
measure: Equinus recurrence rate
timeFrame: Up to 8 years after surgery
measure: Infection rate
timeFrame: Up to 8 years after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Southwest Hospital, China
name: Xiaojun Duan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606385: Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC
Official title: Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Recurrence
Survival
Immunology
Laparoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 84
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: Short-term outcomes of laparoscopic liver resection is better than those of open liver resection

Laparoscopic liver resection is better than open resection in immunological aspects

Detailed description: Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections

1. Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost
2. Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)

Eligibility criteria: Inclusion Criteria:

* Radiologically diagnosed hepatocellular carcinoma
* Child classification A or B
* Aged 20 to 80
* Informed consent taken

Exclusion Criteria:

* Child classification C
* Extrahepatic metastasis
* Tumor located in central area or adjacent to middle hepatic vein
* Recurred hepatocellular carcinoma
* Critically ill patient
* Patient with psychiatric disease

Primary outcomes:
measure: Recurrence rate
timeFrame: 2 years after operation
Secondary outcomes:
measure: Survival
timeFrame: 2 years after operation
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Surgery, Seoul National University Bundang Hospital
name: Ho-Seong Han, MD, PhD
role: STUDY_CHAIR
References:
citation: Yoon YS, Han HS, Choi YS, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic right posterior sectionectomy for hepatocellular carcinoma. J Laparoendosc Adv Surg Tech A. 2006 Jun;16(3):274-7. doi: 10.1089/lap.2006.16.274.
citation: Min SK, Han HS, Kim SW, Park YH, Lee HO, Lee JH. Initial experiences with laparoscopy-assisted and total laparoscopy for anatomical liver resection: a preliminary study. J Korean Med Sci. 2006 Feb;21(1):69-74. doi: 10.3346/jkms.2006.21.1.69.
citation: Yoon YS, Han HS, Choi YS, Lee SI, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic left lateral sectionectomy performed in a child with benign liver mass. J Pediatr Surg. 2006 Jan;41(1):e25-8. doi: 10.1016/j.jpedsurg.2005.10.068.