louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05381285: Survival Model for Preterm Infants
Official title: Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mortality
Morbidity;Newborn
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
name: Swansea Bay University Health Board
First posted: 2022-05-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The whole population of preterm infants born before 34 weeks of gestation for 8 years (2011-2018) in Wales will be included in the retrospective cohort.

Brief summary: Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis


Eligibility criteria: Inclusion Criteria:

1. Preterm infants born alive at or less than 34 weeks of gestation.
2. Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
3. Mother normally resident in Wales

Exclusion Criteria

1. The mother is normally resident in England (detailed maternal data not available)
2. Congenital anomaly noted at birth (alters the natural probability of outcomes)
3. Duplicate episodes for an individual infant

Primary outcomes:
measure: Mortality
timeFrame: 40-weeks
measure: Mortality or major morbidity
timeFrame: 40-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
Study officials:
References:
Clinical trial NCT00631085: Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults
Official title: Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy nonsmoking nonasthmatic volunteers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-03-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease.

We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy nonsmoking volunteers with normal lung function

Exclusion Criteria:

* Chronic illness
* Asthma
* Active allergies

Primary outcomes:
measure: The primary goal of this study is to determine the effect of γT on endotoxin-induced airway inflammation in non-allergic, non-asthmatic subjects.
timeFrame: CCRE challenge after 7 days of treatment with gT or SO
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina CEMALB
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Michelle Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01859585: Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
Official title: Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: preemptive analgesia
lumbar fusion
Parecoxib
Ketorolac
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.

Detailed description: A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale score (0-10), total opioid consumption, complication and bleeding also recorded.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lumbar spinal fusion for one to three levels
* ASA class I or II

Exclusion Criteria:

* History of allergy to Sulfa group
* History of allergy to OPOID or NSAIDs
* Contraindicate to NSAIDs use
* History of coagulopathy or platelet disfunction

Primary outcomes:
measure: Pain score
timeFrame: Postoperative time up to 24 hours
Secondary outcomes:
measure: Total amount of opioid consumption postoperatively
timeFrame: Postoperative 24 hours
Other outcomes:
measure: Amount of drain output and Other Adverse effect
timeFrame: 7 days postoperatively
Locations:
city: Hadyai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Sonkla
Study officials:
affiliation: Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand
name: Koopong Siribumrungwong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siribumrungwong K, Cheewakidakarn J, Tangtrakulwanich B, Nimmaanrat S. Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial. BMC Musculoskelet Disord. 2015 Mar 18;16:59. doi: 10.1186/s12891-015-0522-5.
Clinical trial NCT00420485: Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
Official title: A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Maximum Tolerated Dose
Solid Tumors
Dose Limiting Toxicity
Topoisomerase-1 Inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors


Eligibility criteria: Inclusion criteria:

* Advanced or metastatic cancer
* 18 years and above

Exclusion criteria:

* Previous treatment with 4 or more cycles of carboplatin;
* Previous treatment with 2 or more courses of nitrosourea or mitomycin;
* Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
* Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Presence of dose limiting toxicities in a 56-day treatment period
timeFrame: 56 days
Secondary outcomes:
measure: safety and tolerability assessed by adverse events, serious adverse events
timeFrame: 112 days
measure: pharmacokinetics of gimatecan and its metabolites(s)
timeFrame: 91 days
measure: response rate assessed by anti-tumor activity
timeFrame: 112 days
measure: investigate tumor-specific mutations
timeFrame: 57 days
measure: Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
timeFrame: 56 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: MD Anderson Cancer Center - Orlando
state: Ontario
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Dijon Cedex
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06245785: Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function
Official title: Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function: A Chinese Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study data were extracted from a nationwide database of patients with HCC treated at 15 Chinese centres between January 2012 and December 2022.We included patients who were diagnosed with HCC according to the American Association for the Study of the Liver Disease/European Association for the Study of the Liver Guidelines and who received conventional LR or TACE

Brief summary: Hepatic dysfunction limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. Established practice guidelines for patients with HCC and impaired liver function are lacking. The treatment allocation in these populations is heterogeneous and remains controversial. This study compared the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in patients with HCC and impaired liver function.


Eligibility criteria: Inclusion Criteria:

* patients with HCC who received conventional LR or TACE

Exclusion Criteria:

* （1） presence of portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion
* （2） extrahepatic spread (EHS)
* （3） albumin-bilirubin grade 1 or 3
* （4） Eastern Cooperative Oncology Group Performance Status (ECOG-PS) \>1
* （5） tumour number \>3
* （6） other tumours or severe cardiac, cerebral, and renal insufficiency
* （7）ascites, hepatic encephalopathy, and jaundice

Primary outcomes:
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: Tangdu hospital
state: Shaanxi
city: Xian
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Teachers and students
name: zhao s jie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02423785: Ocular Blood Flow in Colorectal Cancer Patients
Official title: Exploratory Study Investigating Ocular Blood Flow in Colorectal Cancer Patients Before and After Treatment With Anti-angiogenic Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, who are treated at the Medical University of Vienna

Brief summary: In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit from anti-angiogenic approaches, would be highly desirable in order to optimize treatment strategies. Changes in ocular blood flow may be an attractive biomarker for predicting treatment response. In light of the given alternative first line treatment options such a predictive biomarker would be of clinical benefit. In the proposed study the investigators will assess potential changes in the ocular blood flow of mCRC patients after treatment with standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment response as assessed by standard CT-scan


Eligibility criteria: Inclusion Criteria:

* Male or female patients (age 18 and over) suffering from mCRC.
* Normal findings in ophthalmic examination (except the investigator finds an abnormality irrelevant for the purpose of the study.)
* Patients, which are scheduled for standard of care treatment with chemotherapy plus bevacizumab

Exclusion Criteria:

* Refusal to give informed consent
* Severe hypertension (RR ≥180/110)
* Epilepsy
* Pregnancy and breastfeeding women

Primary outcomes:
measure: Correlation between ocular blood flow (retinal blood flow) and treatment response
timeFrame: Within 2-3 months at restaging
measure: Correlation between retinal vessel diameter and treatment response
timeFrame: Within 2-3 months at restaging
measure: Changes in retinal surface before and after therapy as measured by optical coherence tomography
timeFrame: Within 2-3 months at restaging
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01431885: Two Methods of Diagnosing Preterm Labor
Official title: Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Labor
Preterm Delivery
Keywords: fibronectin
cervical length
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.

Detailed description: Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.

Eligibility criteria: Inclusion Criteria:

* symptomatic complaints suggestive of preterm labor
* greater than 6 contractions per hour

Exclusion Criteria:

* multiple gestation
* rupture of amniotic membranes
* chorioamnionitis
* congenital malformations
* persistent vaginal bleeding
* abruptio placentae
* placenta previa
* previously diagnosed short cervix \< 2.5 cm
* cervical dilation \> 3 cm
* cervical cerclage
* exposure to tocolytic drugs
* allergy or contraindication to nifedipine

Primary outcomes:
measure: Delivery prior to 37 weeks' gestation
timeFrame: No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Conrad R Chao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931085: Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)
Official title: "Compassionate Use of Triclabendazole for the Treatment of Parasites" (Prior to FDA Approval; Expanded Access Program)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Parasitic Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-08-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary practice. Triclabendazole is considered to be a second-line drug for parasites and is used when other preferred agents cannot be used because they are ineffective or because adverse reactions limit their use. Although Triclabendazole is widely used in developing countries for the treatment of parasites it is not approved by the FDA for this treatment in the US. It is currently being distributed in the US through a special arrangement with the FDA and the manufacturer on an individual patient approval basis. This arrangement requires that a single patient Investigational New Drug (IND) be obtained from FDA for each patient requiring Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug directly to the prescribing physician.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of parasites whose resistance pattern has indicated resistance to first line agents and sensitivity to Triclabendazole or in whom an additional drug needs to be added to their regimen because of inadequate response to existing therapy.
* Patients with a parasite that is sensitive to Triclabendazole and who have experienced an allergic or adverse reaction to other agents that prevent their use.
* Patients with parasitic disease that has responded to treatment with first line drugs but who experienced allergic or adverse reactions to these agents that has prevented their continued use or who have experienced a relapse in their disease that necessitates the addition, or substitution, of second-line agents
* Patients who do not qualify for a study using Triclabendazole or for whom a study does not exist and thus the patient would not otherwise have access to the drug

Exclusion Criteria:

* Anyone whose parasitic disease can be adequately treated by other available medications.
* Anyone who is allergic or who has had a severe adverse reaction to Triclabendazole in the past.
* Pregnant Women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Marilyn Levi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595985: Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Official title: Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Time to Progression
Toxicity
Overall survival
Response rate
Quality of live
Toxicities
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Detailed description: Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤ 2
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions:

  * platelets\>80 × 109/L
  * neutrophil\>2.0 × 109/L
  * serum creatinine ≤ 1.5mg/dl
  * total bilirubin within upper limit of normal(ULN)
  * serum transaminase ≤ 2.5 × the ULN

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Uncontrolled significant comorbid conditions and previous radiotherapy

Primary outcomes:
measure: time to progression
timeFrame: every six weeks
Secondary outcomes:
measure: toxicity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References: