louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03513666: A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
Official title: Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment：a Multi-center, Single Arm Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study


Eligibility criteria: Inclusion Criteria:

Only the patients meeting all the following criteria can be eligible to participate in the trial:

* Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
* Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
* No exon 20 T790M mutation after failure of EGFR-TKI therapy;
* At least one measurable lesion (in accordance with RECIST 1.1);

Exclusion Criteria:

Patients who fulfill any of the following criteria must be excluded from the study:

* Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component \>10%;
* Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
* Previous systemic chemotherapy for advanced NSCLC;
* EGFR-TKI therapy within two weeks prior to enrollment;

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 12 weeks
Secondary outcomes:
measure: PFS
timeFrame: 18 months
measure: OS
timeFrame: 18 months
measure: DOR
timeFrame: 18 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospita
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhengjiang Cancer Hospital
state: Zhengjiang
Study officials:
References:
Clinical trial NCT03013166: THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone
Official title: Resource Use and Clinical Outcomes in Patients With Adrenal Insufficiency Prescribed Either an Immediate Release or Modified Release Hydrocortisone Formulation or Prednisolone: A THIN (The Health Improvement Network) Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 3000
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: All patients in the THIN database who have a Read code for AI and have been prescribed either IR hydrocortisone or prednisolone or MR hydrocortisone (plenadren) between 2010 and the date of data extraction will be included

Brief summary: To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK.


Eligibility criteria: Inclusion Criteria:

1. Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription of IR hydrocortisone between 2010 and data extraction but no prescription for MR hydrocortisone at any time during this period, and no earlier prescription for IR prednisolone during this period
2. Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of IR prednisolone between 2010 and data extraction but no prescription for MR prednisolone at any time during this period, and no earlier prescription for IR prednisolone during this period
3. Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
4. Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
5. A list of pre-defined READ codes will be used to identify all patients with primary or secondary AI or CAH in the THIN database.

Exclusion Criteria:

1)Patients who have not received a prescription of hydrocortisone or prednisolone in the past five years will be excluded as the aim of the study is to describe recent experience.

Primary outcomes:
measure: Primary care resource use per year in all patients as measured by using number of primary care contacts
timeFrame: 4 months
measure: Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
timeFrame: 4 months
measure: Primary care resource use per year in all patients as measured by number of sick notes issues
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00055666: Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
Official title: Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Versus Host Disease
Keywords: graft versus host disease
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2003-03-07
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.

PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

Detailed description: OBJECTIVES:

* Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
* Minimize the serious side effects associated with systemic steroid use in these patients.

OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract

  * Failed standard therapy with or has a contraindication to systemic immunosuppressive agents
* No clinically significant intestinal infection (confirmed by stool culture)
* No persistent vomiting of all oral intake
* Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol

PATIENT CHARACTERISTICS:

Age

* 4 to 70

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to swallow medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Philip L. McCarthy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02411266: Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage
Official title: Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Preconditioning
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 57
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 purpose of this study is to learn about protecting the brain from dangerous low blood flow.


Eligibility criteria: Inclusion Criteria:

* Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment.
* Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.

Exclusion Criteria:

* Hunt Hess Scale \> 4
* Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
* Inability to obtain informed consent from the patient or a health care proxy.
* Ankle-brachial index \< 0.7
* Inability to start limb preconditioning within 4 days of bleeding.
* Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography
* Age\<18 years
* Pregnant women
* Prisoners

Primary outcomes:
measure: Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism
timeFrame: 90 days
measure: Safety Outcome 2 - number of patients who develop neurovascular injury
timeFrame: 90 days
measure: Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
timeFrame: 90 days
measure: Safety Outcome 4 - number of patients with cardiovascular events
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
measure: Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2
timeFrame: 90 days
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sebastian Koch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229866: Feeding After Neonate Surgery Review
Official title: Feeding After Neonatal Surgery Chart Review
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: newborn
pediatric health
Feeding difficulty
discharge with a NG tube
G-tube placement
Nissen fundoplication
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates who undergo cardiac surgery

Brief summary: The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.

Detailed description: The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.

The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation.

Eligibility criteria: Inclusion Criteria:

* Neonates who undergo cardiac surgery

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017666: BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects
* Between the ages of 18 and 45, inclusive.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

* Clinically significant abnormalities (as determined by the Investigator)
* Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

Primary outcomes:
measure: Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo
timeFrame: 24 hours (Cohort 1); 144 hours (Cohort 2)
Secondary outcomes:
measure: Adverse Events
timeFrame: Duration of subject participation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: InCROM Clinical Research Unit
Study officials:
References:
Clinical trial NCT00315666: Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Official title: Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tension-Type Headache
Keywords: Chronic tension-type headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.


Eligibility criteria: Inclusion Criteria:

* Chronic tension-type headache
* Normal urine pH

Exclusion Criteria:

* More than 1 migraine attack/month
* Other major illnesses
* Overuse of medicine/alcohol
* Women not using AC
* Pregnant/breast-feeding women
* Allergy to memantine

Primary outcomes:
measure: Headache duration
measure: Headache intensity
Secondary outcomes:
measure: Headache frequency
measure: The use of simple analgesics
measure: Side effects
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headaches Center
Study officials:
affiliation: Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup
name: Lars Bendtsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810666: Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Official title: Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 30
Sex: MALE
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.


Eligibility criteria: Inclusion Criteria:

* Male, aged 2-16yrs
* Severe hemophilia A (\<1% FVIII:C \[Blood Clotting Factor VIII:C\] )
* Minimum of at least 50 documented ED (exposure day) prior to enrolment
* No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
* Parents or legal guardians document, sign, and date informed consent

Exclusion Criteria:

* Another bleeding disease that is different from hemophilia A
* Known hypersensitivity to the active substance, mouse or hamster protein
* Thrombocytopenia (platelet count \<100 000/mm3) based on previous medical records

Primary outcomes:
measure: Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period
timeFrame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
Secondary outcomes:
measure: Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period
timeFrame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
measure: Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period
timeFrame: From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Beijing
country: China
city: Beijing
country: China
city: Tianjin
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01106066: Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT
Official title: A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Phase I: To Determine the Maximum Tolerated Dose (MTD)
Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 30
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: To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years

  * Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)

    * ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form

Exclusion Criteria:

* T1 (regardless of N stage), T2N0

  * M1 ③ Peritoneal seeding ④ Uncontrolled medical condition

Primary outcomes:
measure: MTD/pathologic CR
timeFrame: at the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Cancer Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ki Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01141166: Octabaix Intervention Study
Official title: A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Falls
Malnutrition
Keywords: ELDERLY
NUTRITION
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
First posted: 2010-06-10
Enrollment: 328
Sex: ALL
Minimum age (years): 85
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.

Detailed description: Design: Randomized, controlled trial.

Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.

The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.

Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.

Eligibility criteria: Inclusion Criteria:

* Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized

Exclusion Criteria:

* Institutionalized

Primary outcomes:
measure: Rate of falls and rate of undernutrition risk as MNA < 23,5
Secondary outcomes:
measure: Different geriatrics characteristics
Other outcomes:
Locations:
city: sant Feliu de Llobregat
country: Spain
facility: Assumpta Ferrer Feliu
state: Barcelona
Study officials:
References:
citation: Badia T, Formiga F, Ferrer A, Sanz H, Hurtos L, Pujol R. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study. BMC Geriatr. 2015 Apr 11;15:45. doi: 10.1186/s12877-015-0033-0.
citation: Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.