louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00512083: Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
Official title: An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid
Keywords: Leukemia, Myeloid + Acute Disease
Lead sponsor: Antisoma Research
Sponsor class: INDUSTRY
First posted: 2007-08-07
Enrollment: 70
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 overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

* primary refractory or relapsed AML
* confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
* aged at least 18 years

Exclusion Criteria:

* initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
* patient in blast crisis stage of chronic myeloid leukemia
* received high-dose cytarabine (total cumulative dose of \>6g/m sq)in last 6 months
* interval of \<6 months between first onset of last complete remission and current relapse
* those with primary refractory leukemia who have received more than three previous induction cycles
* relapsed patients who have received more than three previous treatment regimens

Primary outcomes:
measure: The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Univeristy of Colorado Health Cancer Center
state: Colorado
city: Beech Grove
country: United States
facility: St. Francis Hospital and Health Center
state: Indiana
city: Louisville
country: United States
facility: University of Louisville, James Graham Brown Cancer Center
state: Kentucky
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center - Institute for Drug development
state: Texas
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
References:
Clinical trial NCT06496009: The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients
Official title: The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients: A Real-world Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSCLC
Keywords: NSCLC
PD-L1 negative
immunotherapy
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.

Brief summary: This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.

Detailed description: This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice. Clinical treatment of patients will not be intervened unless disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances deemed appropriate by the investigator to discontinue treatment, whichever occurs first. The primary objective of the study is for investigators to assess the one-year progression-free survival (PFS) rate of immunotherapy as first-line treatment in PD-L1 negative advanced or metastatic NSCLC, evaluated according to RECIST 1.1 criteria.

Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before implementing any trial-related procedures;
* Aged 18-80 years;
* Wild-type EGFR/ALK;
* Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
* PD-L1 negative；
* Patients receiving first-line immunotherapy (such as PD-1/PD-L1 inhibitors).

Exclusion Criteria:

* The patient refused to join this study and declined follow-up.

Primary outcomes:
measure: 1-year Progression-Free Survival (PFS) rate
timeFrame: up to 12 month
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: up to 24 months
measure: Overall Survival
timeFrame: up to 36 months
measure: Objective Response Rate
timeFrame: up to 9 month
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Chunxia Su, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT01760109: Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Official title: Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Tract Infections
Urinary Tract Infections
Keywords: Respiratory and urinary tract infections
Piperacillin Sodium and Sulbactam Sodium for Injection (2:1)
Phase IV
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-01-03
Enrollment: 2000
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
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.

Detailed description: Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Eligibility criteria: Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Primary outcomes:
measure: The rate of bacterial clearance
timeFrame: two years
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: two years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Red Cross hospital
Study officials:
affiliation: Chongqing Red Cross Hospital
name: Changqing Li, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303809: Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Official title: Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Perioperative care
Fast-track
Enhanced Recovery After Surgery
ERAS
Obesity
Bariatric surgery
Laparoscopic Sleeve Gastrectomy
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Auckland Medical Research Foundation
First posted: 2011-02-25
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to standardise and optimise perioperative care for consecutive patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will compare patients under a standardised perioperative care program to patients who undergo routine perioperative in our hospital and determine whether patients who had optimised perioperative care went home earlier and had fewer complications.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
* Surgery occurs at Manukau Surgery Centre

Exclusion Criteria:

* Surgery not occuring in Manukau Superclinic

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: day of discharge
Secondary outcomes:
measure: Complications
timeFrame: 30 days
measure: Readmission rates
timeFrame: 30 days
measure: Postoperative fatigue
timeFrame: Baseline and postoperative days 1, 7 and 14
measure: Compliance to the ERAS protocol
timeFrame: through to day 1 postoperatively
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Manukau Surgery Centre
Study officials:
References:
citation: Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
Clinical trial NCT06427109: Omega-3 Fatty Acid and Colorectal Adenoma
Official title: Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Adenoma Colon
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 798
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multi-center, nationwide cohort in Korea

Brief summary: Patients aged \>40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis.


Eligibility criteria: Inclusion Criteria:

* all patients aged more than 40 years of age, scheduled for elective colonoscopy.

Exclusion Criteria:

* inflammatory bowel diseases
* history of colorectal neoplasms
* prior gastrointestinal surgery
* substance abuse including alcohol
* an inability to complete the survey due to emergency endoscopy
* cognitive impairments and those undergoing significant dietary modifications

Primary outcomes:
measure: Incidence of Colorectal adenoma
timeFrame: at the completion of the colonoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi Province
Study officials:
affiliation: DongGuk University
name: Yun Jeong Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06544109: Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Official title: Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Acute Promyelocytic Leukemia
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
2. patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \&lt; 45 mL/min. Moderate hepatic impairment with total bilirubin \&gt; 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.

Exclusion Criteria:

1. Patient is ineligible for treatment with intensive chemotherapy
2. Patient with active infection not controlled, active bleeding from vital organs
3. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study

Primary outcomes:
measure: the rate of differential symdrom
timeFrame: the induction regimen (21 days to 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Qiu huiying
state: Jiangsu
Study officials:
References:
Clinical trial NCT03507283: Vertical Split Conjunctival Autograft in Double-head Pterygia
Official title: Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-head Pterygia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pterygium of Conjunctiva and Cornea
Keywords: Pterygium
double-headed
vertical
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included 15 eyes of 15 patients. The mean age of all patients was 36.92 ± 10.8 years. There were 9 males (60%) and 6 females (40%).

Brief summary: 15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over the limbus onto the cornea.

Vertical split conjunctival autograft using fibrin glue is an effective technique with good cosmetic results and low to no recurrence for primary double head pterygia treatment.

Detailed description: The pterygium body was dissected from the sclera. Complete excision of the pterygium, subconjunctival Tenon's tissue and surrounding fibrovascular tissues followed.The conjunctival edge was trimmed. The corneal surface was gently scraped with a scalpel. The Same procedure was done on temporal pterygia. A free conjunctival autograft was obtained. The graft was divided vertically into two parts. The nasal part of the graft was cut from limbal attachment including limbal tissue; temporal part was left attached. The nasal part of the graft was moved to the nasal conjunctival defect and attached to the sclera with fibrin sealant (Tisseel; Baxter, Vienna, Austria). The Same procedure was done with the temporal part of the graft. The orientation of graft was ensured before securing it.

Eligibility criteria: Inclusion Criteria:

* Primary double-headed pterygia

Exclusion Criteria:

* NONE

Primary outcomes:
measure: The recurrence rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Elhamaky TR, Elbarky AM. Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-Headed Pterygia. J Ophthalmol. 2018 Dec 20;2018:9341846. doi: 10.1155/2018/9341846. eCollection 2018.
Clinical trial NCT04984083: Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
Official title: Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin K
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Faculty of Medicine, Minia University
First posted: 2021-07-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.


Eligibility criteria: Inclusion Criteria:

1. Age from 20-40 years.
2. Gestational age between 36-39 weeks.
3. Patients who will undergo an elective cesarean section.
4. Full-term alive baby.
5. Non-scarred uterus.
6. No obstetric or medical complications.
7. No bleeding tendency.

Exclusion Criteria:

1. Patients at less than 36 gestational weeks.
2. Patient refusal.
3. Patients who have thrombo-embolic complications.
4. Patients with obstetric and medical complications.
5. Patients with anomalous fetuses.
6. Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs.
7. Patients with obstetric cholestasis.
8. Patients with a previous history of preterm labor.
9. Patients with multiple pregnancies.
10. Gestational hypertension or preeclampsia.
11. Blood clotting disorders.
12. Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta.
13. Placental abruption and Placenta previa.

Primary outcomes:
measure: Blood loss (measured in cc)
timeFrame: During Cesarean Section
measure: Prothrombin time of the mother (measured in seconds)
timeFrame: 6 hour postmartum
measure: Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)
timeFrame: 6 hour postmartum
measure: Prothrombin Concentration (PC) of the mother (measured in %)
timeFrame: 6 hour postmartum
measure: Prothrombin time of the newborn (measured in seconds)
timeFrame: immediately after birth
measure: Prothrombin Concentration (PC) of the newborn (measured in %)
timeFrame: immediately after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
References:
Clinical trial NCT03932071: Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Official title: The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lung Metastases
Tumor Necrosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Zoledronic acid is an adjuvant treatment for primary osteosarcoma. Zoledronic acid has been widely used in the treatment of metastatic bone tumors. In addition to its inhibition of tumor osteoclasis, it also produces certain killing of tumor cells. effect. Foreign studies have shown that zoledronic acid also has a killing effect on osteosarcoma and has a certain inhibitory effect on distant metastasis. We hope that it can reduce tumor recurrence and lung metastasis through this study.


Eligibility criteria: Inclusion Criteria:

* Patients with osteosarcoma who were diagnosed with initial pathology and pathology were excluded from lung metastasis or other metastatic lesions by CT and total body emission-computed tomography, and patients with standard chemotherapy were evaluated.

Exclusion Criteria:

* Pulmonary metastasis, pregnancy or lactation, renal insufficiency (creatinine clearance \<70 ml/min/1.73 m2), liver dysfunction, obvious oral disease, and unsuitable for bisphosphonate treatment after evaluation, have been found. With diseases that still require hormone therapy, abnormal blood system, heart disease

Primary outcomes:
measure: rate of lung metastasis
timeFrame: 3 year
measure: rate of tumor recurrence
timeFrame: 3 year
Secondary outcomes:
measure: rate of tumor necrosis less than 90%
timeFrame: 3 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital Of Zhejiang University
name: zhaoming Ye, Prof.
role: PRINCIPAL_INVESTIGATOR
References: