louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01589549: Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
Official title: A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute GVH Disease
Keywords: Acute graft versus host disease
Bone marrow transplantation
Mesenchymal stromal cells
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
Collaborators: name: Royal Perth Hospital
First posted: 2012-05-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.

It is hypothesised that mesenchymal stromal cell therapy will be superior

Detailed description: Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals

Eligibility criteria: Inclusion Criteria:

* Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
* Age 18-55 years

  * Must be receiving a calcineurin inhibitor

Exclusion Criteria:

* Failure to sign informed consent
* Corticosteroid therapy for 72 hours or greater
* ECOG score equal to or greater than 3

Primary outcomes:
measure: Survival at one year after onset of graft versus host disease
timeFrame: One year
Secondary outcomes:
measure: Response at 14 days after commencement of treatment for acute graft versus host disease
timeFrame: 14 days
measure: Response at 28 days after commencement of treatment of acute graft versus host disease
timeFrame: 28 days
measure: Incidence of severe infection
timeFrame: One year
measure: Disease free survival at one year
timeFrame: One year
measure: Time to treatment failure, requiring salvage therapy
timeFrame: 28 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: Royal Perth Hospital
name: Duncan Purtill, MB, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874949: Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone
Official title: Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Obturation
Lead sponsor: ACTEON Group
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2019-03-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.

The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.


Eligibility criteria: Inclusion Criteria:

* male or female aged from 18 to 70 years,
* patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar),
* Informed consent signed,
* Patient with social protection.

Exclusion Criteria:

* root canal retreatment,
* root canal treatment on an immature tooth,
* calcified root canal assessed radiographically,
* Patient with one or more documented contraindication to endodontic treatment,
* Patient who takes regular analgesic or anti-inflammatory therapy for another pathology,
* Known allergy to NSAID or to one component of the sealer formula,
* Participation to another clinical trial at the same time,
* known pregnancy or lactation,
* Patients with legal protection.

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Pain response profil
timeFrame: 0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7
measure: Use of oral pain treatment
timeFrame: 7 days
measure: Adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: Cabinet dentaire
Study officials:
affiliation: Private dental practice
name: Hugues Colombel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195649: Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy
Official title: Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Renal Cell
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese patients

Brief summary: The primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with Nexavar® has been made under real-life practice settings and approved reimbursement restriction in Taiwan. Therefore, the main objective of the study is to collect data on:

Prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data

Nexavar® treatment and efficacy data

Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Nexavar® under Taiwan reimbursement guideline
* Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

* Exclusion criteria must follow the approved local product information.
* Patients were lost to follow-up if no follow-up visit and no final assessment of Nexavar® was documented.

Primary outcomes:
measure: Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of number of adverse events)
timeFrame: After one year
measure: Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of changes in tumor status)
timeFrame: After one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01271049: An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths
Official title: A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Helminthiasis
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: TyraTech Technology
First posted: 2011-01-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.


Eligibility criteria: Inclusion Criteria:

* Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
* Showing presence of no or mild-moderate helminths

Exclusion Criteria:

* Presence of heavy helminth load
* Pregnant or lactating
* Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine

Primary outcomes:
measure: Measure of Safety and Tolerability using the Reactogenicity Questionairre
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minas Gerais
country: Brazil
facility: Centro de Pesquisas Rene Rachou-FIOCRUZ
Study officials:
affiliation: Rene Rachou Research Center, Brazil
name: David Diemert, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00904449: Open Label Assessment of Long-Term Safety and Utility
Official title: An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.


Eligibility criteria: Inclusion Criteria:

* Males or females aged \> 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics.
* Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study.
* Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible.

Exclusion Criteria:

* Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication.
* Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication.
* Known idiosyncratic reaction or hypersensitivity to oxymorphone.
* Inability to take oral medication for 1 week.
* Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.

Primary outcomes:
measure: Assessment of AEs and clinical laboratory values
timeFrame: 22 months
Secondary outcomes:
measure: Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer
timeFrame: 22 months
Other outcomes:
Locations:
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05035849: Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
Official title: Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.

Detailed description: In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with two groups. Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. The opposite therapy was true for patients in group B.

Eligibility criteria: Inclusion Criteria:

1. Participate voluntarily and sign the subject informed consent before the test.
2. Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
3. No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
4. Subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. Patients allergic to insulin.
2. Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
3. A history of drug abuse and alcohol dependence within the past 5 years.
4. Systemic hormone therapy was used in recent 3 months.
5. Patients with poor compliance and irregular diet and exercise.
6. Patients with infection and stress within four weeks.
7. Patients who cannot tolerate flash glucose mornitoring(FGM).
8. Patients who are pregnant, nursing or preparing to become pregnant.
9. Any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.

Primary outcomes:
measure: Glycemic variations
timeFrame: Endpoint at the third month
Secondary outcomes:
measure: Glycemic variations
timeFrame: Endpoint at the third month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Gu Gao
Study officials:
affiliation: Nanjing First Hospital, Nanjing, Jiangsu, China, 210012
name: Jianhua Ma, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01930149: Promoting Cholesterol Screening
Official title: Reducing Disparities in Primary Prevention of Cardiovascular Disease: Promoting Cholesterol Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lipid Testing
Primary Prevention of Cardiovascular Disease
Keywords: Cholesterol screening
High cholesterol
Cardiovascular disease
Statin treatment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-08-28
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of preventive services, including in safety net settings, we will implement patient-directed reminders to health center patients who meet our eligibility criteria.

The aim of this study is to determine if a mailed outreach message and facilitated ordering of screening lipid tests increases cholesterol screening test completion within 3 months among federally qualified community health center patients who are eligible for screening compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Patient at participating health center
* At least 1 visit to clinic in the prior 12 months
* No total cholesterol and high-density lipoprotein cholesterol result recorded in the electronic health record in the past 5 years
* No cholesterol screening order placed within the previous 3 months
* Men 35-75 years old, or women 45-75 years old who also have one of the following: hypertension, obesity, or current smoking

Exclusion Criteria:

* Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
* Statin on active medication list
* Preferred language other than English or Spanish

Primary outcomes:
measure: Completion of total cholesterol and HDL cholesterol test or full lipid panel
timeFrame: within 3 months of outreach
Secondary outcomes:
measure: Statin prescription
timeFrame: within 3 months of outreach
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: North Country Health Care
state: Arizona
city: Chicago
country: United States
facility: Near North Health Service Corporation
state: Illinois
city: Chicago
country: United States
facility: Heartland Health Outreach
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen D Persell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587949: The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.
Official title: The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Stroke
Keywords: acute cerebrovascular stroke
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients aged 40-80.
2. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
3. Rankin 0-1 before the event

Brief summary: In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after.

Detailed description: The study will include patients hospitalized due to an acute cerebrovascular stroke. A number of 30 patients aged 40-70 will be included. Within 48 hours of the event, blood inflammatory biomarkers, and scalp hair sample for cortisol will be taken. All recruited patients will undergo full neurological examination and the severity of the stroke will be rated using NIHSS (National Institutes of Health Stroke Scale). 3 months and one year later neurological examination and rating of neurological disability will be determined using Rankin Scale.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 40-80.
2. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
3. Rankin 0-1 before the event

Exclusion criteria:

1. Suspicion or known Cushing's syndrome
2. Known adrenal failure
3. Chronic inflammatory disease
4. Active malignancy
5. Acute infectious disease within 4 months before enrollment

Primary outcomes:
measure: Anti Tumor Necrosis Factor alpha
timeFrame: 24 months
measure: C-reactive protein levels
timeFrame: 24 months
measure: Hair Cortisol level
timeFrame: 24 months
measure: INL-6
timeFrame: 24 months
Secondary outcomes:
measure: TSH
timeFrame: 24 months
measure: FT4
timeFrame: 24 months
measure: FT3
timeFrame: 24 months
measure: Cortisol
timeFrame: 24 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Mira Koch
Study officials:
References:
Clinical trial NCT03843749: Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Official title: Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: HER2
Pyrotinib
Trastuzumab
Metastatic Colorectal Cancar
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 30
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: This clinical trial aims to evaluate the efficacy, safety of Pyrotinib in combination with trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.


Eligibility criteria: Inclusion Criteria:

Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
References: