louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00517699: A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
Official title: An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With Primary Central Nervous System Lymphoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* histological diagnosis of primary central nervous system lymphoma;
* B-cell proliferation verified by positive staining for CD20;
* \>=1 measurable lesion.

Exclusion Criteria:

* prior chemotherapy, other than corticosteroids, \>=6 weeks before and after diagnosis or surgery;
* history of prior cranial irradiation;
* evidence of plurisystemic non-Hodgkin's lymphoma;
* other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix;
* uncontrolled active infection.

Primary outcomes:
measure: Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
timeFrame: Week 24
measure: Percentage of Participants With a CR, CRu or Partial Response (PR)
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse
timeFrame: Week 24
measure: Overall Survival
timeFrame: Time of last follow-up assessment between Day 1 and 3 years
measure: Progression-Free Survival (PFS)
timeFrame: Week 24
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03623399: Laparoscopic Gas Pressure and Postoperative Pain Score
Official title: Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Laparoscopy
Keywords: postoperative pain
Intraabdominal laparoscopic gas pressure
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 195
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.

Detailed description: In this study investigator planned to randomize patients into three groups ; in the first group abdominal entrance pressure will be 15 mmhg and intraoperative pressure will be 15 mmhg too ; in the second group again entrance pressure will be 15 mmhg , intraoperative pressure will be 12 mmhg ; and in the thirth group both entrance and intraoperative pressures will be 12 mmhg. During operation intraoperative mean pressures will be recorded every 15 minutes , also end tidal CO2 pressures will also assesed by the anesthesiologist. Every participant will take , same standard analgesics ; 2 mg/kg contramal and 1 gr i.v. paracetamol at the end of the operation ; except the ones who has allergy to these analgesics. At postoperative 6 th and 24 th hours patients will be asked to execute the visual analogue score (VAS) form to assess the pain . Only patients with benign gynecologic pathologies will be included in to the study and informed consent forms will be taken from all participants.

Eligibility criteria: Inclusion Criteria:

* benign gynecologic pathologies which requires laparoscopic surgery

Exclusion Criteria:

* patients who has malign gynecologic pathologies

Primary outcomes:
measure: postoperative pain scores
timeFrame: Postoperative 6 th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Seda Yuksel Simsek
Study officials:
affiliation: Baskent University
name: Husnu Celık, Prof.
role: STUDY_CHAIR
References:
citation: Koc M, Ertan T, Tez M, Kocpinar MA, Kilic M, Gocmen E, Aslar AK. Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum. ANZ J Surg. 2005 Aug;75(8):693-6. doi: 10.1111/j.1445-2197.2005.03496.x.
Clinical trial NCT01395199: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Official title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thalassemia
Iron Overload
Keywords: Magnetic resonance imaging
Thalassemia
Iron overload
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-07-15
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

1. Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
2. No anticipated changes in chelation regimen for the next 12 months
3. Completed and signed Informed Consent

Exclusion Criteria:

1. Pregnancy
2. Advanced class III/IV heart failure or LVEF \< 0.35% (by MRI)
3. Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
4. Advanced heart AV block

Primary outcomes:
measure: Myocardial T2* values (msec)
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Liver T2* values (msec)
timeFrame: 6 and 12 months
measure: Serum ferritin levels
timeFrame: 6 and 12 months
measure: left ventricle volumes and function
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas
state: SP
Study officials:
affiliation: University of Campinas, Brazil
name: Juliano L Fernandes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes JL, Loggetto SR, Verissimo MP, Fertrin KY, Baldanzi GR, Fioravante LA, Tan DM, Higa T, Mashima DA, Piga A, Coelho OR, Costa FF, Saad ST. A randomized trial of amlodipine in addition to standard chelation therapy in patients with thalassemia major. Blood. 2016 Sep 22;128(12):1555-61. doi: 10.1182/blood-2016-06-721183. Epub 2016 Jul 13.
Clinical trial NCT02171299: Intraoperative Local Anaesthetic and Postoperative Pain
Official title: Intraoperative Wound Infiltration With Local Anaesthetic in Surgical Patients; Is There Any Late Effect on the Postoperative Pain and the Requirements of Analgesia ? A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Hellenic Red Cross Hospital
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.

Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period.

Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .


Eligibility criteria: Inclusion Criteria:

* Patients with conditions that require surgery ( general surgery)
* Must be able to comprehent the questions , fill documents, communicate well with the doctors
* Patients who will have at least one surgical incision under general or regional anaesthesia

Exclusion Criteria:

* Patients who could not comprehend well
* patients who remained intubated even for one postoperative day
* Patients who were discharged the day of the operation

Primary outcomes:
measure: Intensity of postoperative pain
timeFrame: six days
Secondary outcomes:
measure: Quantity and quality of the required postoperative analgesia
timeFrame: six days
Other outcomes:
measure: type of analgesia required postoperatively
timeFrame: six days
Locations:
city: Athens
country: Greece
facility: "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece
Study officials:
References:
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
citation: Lanitis S, Karkoulias K, Sgourakis G, Brotzakis P, Armoutides V, Karaliotas C. The late effect of intraoperative wound infiltration with local anaesthetic in surgical patients; is there any? A randomized control trial. Int J Surg. 2015 Aug;20:35-40. doi: 10.1016/j.ijsu.2015.05.053. Epub 2015 Jun 11.
Clinical trial NCT01505699: Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia
Official title: Micro RNA Expression Analysis in B-Lineage Adult Acute Lymphoblastic Leukemia From ALL Trial, E2993, Including Patients With Various Cytogenetic and Molecular Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute lymphoblastic leukemia in remission
B-cell adult acute lymphoblastic leukemia
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-06
Enrollment: 186
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E2993 who provided samples for research

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.

Detailed description: OBJECTIVES:

* To identify microRNAs that behave as oncogenes or as tumor suppressor genes in B-lineage acute lymphoblastic leukemia (ALL) in vitro and in vivo.
* To examine if single microRNA or signatures of microRNA correspond to different clinical outcomes in cytogenetically distinct B-ALL groups.

OUTLINE: RNA from archived samples are analyzed for microRNA expression profile in vitro and in vivo.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Samples from patients enrolled on ECOG-2993
* Samples from patients with recurrent cytogenetic abnormalities other than BCR-ABL, including MLL/AF4, E2A/PBX1, and TEL/AML1

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Comprehensive view of microRNA expression by cytogenetic subgroup
timeFrame: 1 year
measure: MicroRNA expression in relation to clinical outcome
timeFrame: 1 year
measure: Differential microRNA expression between normal B-cells and progenitors compared to B-ALL
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hans-Guido Wendel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906099: Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.


Eligibility criteria: Inclusion Criteria:

* subjects aged more than 30 years
* no history of chronic diseases
* no use of blood glucose lowering drugs be wiling to participate to study

Exclusion Criteria:

* do not follow study protocol
* incidence of chronic diseases during the study
* to start use of blood glucose lowering drugs or to change dose and type of current medications

Primary outcomes:
measure: Fasting blood glucose (mg/dl)
timeFrame: 14 weeks
Secondary outcomes:
measure: Hemoglobin A1C (%)
timeFrame: 14 weeks
measure: Total cholesterol (mg/dl)
timeFrame: 14 weeks
measure: Low Density Lipoprotein (mg/dl)
timeFrame: 14 weeks
measure: High Density Lipoprotein (mg/dl)
timeFrame: 14 weeks
measure: Triglyceride (mg/dl)
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References:
Clinical trial NCT02219399: DHA Supplementation and Pregnancy Outcome
Official title: Maternal DHA Supplementation and Pregnancy Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
DHA
Gestational Length
Cognitive Development
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2014-08-18
Enrollment: 871
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Detailed description: This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* 18 years of age or older

Exclusion Criteria:

* cervical incompetence
* presence of cervical cerclage
* placenta previa
* intrauterine infection
* known substance abuse
* multiple fetuses
* current pre-eclampsia
* preexisting diabetes

Primary outcomes:
measure: Gestational Length
timeFrame: 13 weeks
measure: Cognitive Development
timeFrame: 4 months
measure: Cognitive Development
timeFrame: 12 months
Secondary outcomes:
measure: Infant birth length
timeFrame: 13 weeks
measure: Infant Growth Velocity
timeFrame: 2 months to 4 months of age
measure: Infant birth weight
timeFrame: 13 weeks
measure: Infant head circumference at birth
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Hospitals and Clinics
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Mary A Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982899: A Web-based Calculator Predicts Heterogeneous Frailty Trajectories
Official title: A Web-based Calculator Predicts Heterogeneous Frailty Trajectories Among Elderly Gastric Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 412
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly gastric cancer survivors

Brief summary: To explore the predictive factors of frailty trajectories and develop a web-based nomogram among gastric cancer survivors.

Detailed description: The aims of this study are to explore the predictive factors of frailty trajectories in gastric cancer patients more comprehensively based on the health ecology theory and to construct a clinically convenient web-based prediction calculator, so as to screen high-risk frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to implement early interventions to improve the prognosis.

Eligibility criteria: Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology;
* age ≥60 years old;
* radical gastrectomy was proposed;
* be able to communicate simply in writing and verbally.

Exclusion Criteria:

* combined with other sites of malignant tumors;
* combined with severe heart, liver, lung, and renal insufficiency;
* recent using hormones, immunosuppressants;
* with physical disabilities.

Primary outcomes:
measure: frailty trajectories
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Xueyi Miao
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing medical university
Study officials:
References:
Clinical trial NCT02966899: Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
Official title: Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary; Hypertension
Steatosis
Right Ventricular Failure
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
First posted: 2016-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.

Detailed description: The investigators propose to treat 30 participants that are identified as having elevated myocardial triglyceride content (defined as greater than 0.50%) on cardiac MRI with 4 grams of omega-3 fatty acids daily for six months with a primary end point of reducing right ventricular steatosis and a secondary endpoint of improving RV systolic function. The investigators hypothesize that right ventricular steatosis by cardiac MRI will be associated with the degree of right ventricular systolic function by cardiac MRI. In the subset of participants with elevated baseline steatosis who are treated with a lipoprotective strategy, the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce myocardial steatosis and improve right ventricular systolic function.

Eligibility criteria: Inclusion Criteria:

* Adult men and women \> 30 years of age with a diagnosis of pulmonary hypertension (defined as mean pulmonary arterial pressure ≥25 mmHg at rest on right heart catheterization)

Exclusion Criteria:

* Contraindication to MRI (e.g., metallic hazards or allergy to gadolinium)
* Renal dysfunction (eGFR \< 60 ml/min/1.73m2 as estimated by the Modified Diet in Renal Disease formula)
* High risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal transplant)
* Active pregnancy or breastfeeding (determined by urinary pregnancy test before CMR)
* Weight \> 550 lb or waist diameter \> 70 cm (limits for our Siemens Verio CMR system)
* Fish Allergy

Primary outcomes:
measure: Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
timeFrame: 6 months
Secondary outcomes:
measure: Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
Study officials:
References: