louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04359992: Study of Hemostasis in Case of Severe COVID-19
Official title: Study of Hemostasis in Case of Severe COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 50
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: Adult patients hospitalized in intensive care for severe COVID-19 infection

Brief summary: The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group

Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.

In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.


Eligibility criteria: Inclusion Criteria:

* Adult patient (\<18y)
* With a SARS-CoV-2 infection confirmed by RT-PCR
* Hospitalized in intensive care

Exclusion Criteria:

* Patients under guardianship/curator
* Anemia at 7 g/dL at inclusion

Primary outcomes:
measure: Platelet activation intensity with the occurrence of clinical thrombotic complications
timeFrame: Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tacquard C, Mouriaux C, Delabranche X, Bourdon C, Eckly A, Magnenat S, Sattler L, Gachet C, Mertes PM, Hechler B, Mangin PH. Platelet dysfunction and thrombus instability in flow conditions in patients with severe COVID-19. Thromb Res. 2023 Jan;221:137-148. doi: 10.1016/j.thromres.2022.11.004. Epub 2022 Nov 8.
Clinical trial NCT02636192: Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents
Official title: Incidence of Diabetic Ketoacidosis Among Patients With Type 2 Diabetes Mellitus Treated With SGLT2 Inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using 4 Administrative Claims Databases in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Sodium-glucose co-transporter 2 inhibitors
Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with type 2 diabetes mellitus (T2DM) and initiated on sodium-glucose co-transporter 2 inhibitors (SGLT2i) or other Antihyperglycemic Agents (AHAs) were observed.

Brief summary: The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.

Detailed description: This study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the US. Participants diagnosed with T2DM and initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs), DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of DKA in the different AHA new-user groups.

Eligibility criteria: Inclusion Criteria:

* At least 1 antihyperglycemic agents (AHA) prescription (Rx) during the study period, between 4/1/2013 and 9/30/2014.
* Diagnosed of type 2 diabetes mellitus
* Enrollment history of at least 12 months
* Having prescription drug coverage
* Having no prescription of the index drug during the 6 months prior

Exclusion Criteria:

- Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary diabetes mellitus (SDM) any time after index date.

Primary outcomes:
measure: Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04792892: ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
Official title: ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 600
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 newly diagnosed anal cancer

Brief summary: Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.

The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Anal squamous carcinoma diagnosed within the last 2 months

Exclusion Criteria:

-No informed consent

Primary outcomes:
measure: QoL
timeFrame: 3 months after diagnosis
measure: Urinary function
timeFrame: 3 months after diagnosis
measure: Bowel function
timeFrame: 3 months after diagnosis
measure: Sexual function
timeFrame: 3 months after diagnosis
measure: Toxicity related to treatment
timeFrame: 3 months after diagnosis
Secondary outcomes:
measure: QoL
timeFrame: 12 months after diagnosis
measure: Urinary function
timeFrame: 12 months after diagnosis
measure: Bowel function
timeFrame: 12 months after diagnosis
measure: Sexual function
timeFrame: 12 months after diagnosis
measure: QoL
timeFrame: 3 years after diagnosis
measure: Urinary function
timeFrame: 3 years after diagnosis
measure: Bowel funcction
timeFrame: 3 years after diagnosis
measure: Sexual function
timeFrame: 3 years after diagnosis
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT01078792: Prognostic Value of Prothrombin Fragments 1+2 for Pulmonary Embolism Incidence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Disease Exacerbation
Pulmonary Embolism
Prothrombin Fragments
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-02
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 admitted to hospital due to COPD exacerbation

Brief summary: To determine the possible association of prothrombin fragments 1+2 elevation with incidents of pulmonary embolism in patients with COPD exacerbation.


Eligibility criteria: Inclusion Criteria:

* COPD exacerbation
* Able to give informed consent
* Able to perform spirometry

Exclusion Criteria:

* Known malignancy
* Known hypercoagulable state
* Receiving anticoagulant treatment
* Pregnancy
* Renal failure
* Allergy to Iodine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03539692: Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
Official title: Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Food Allergy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institutes of Health (NIH)
First posted: 2018-05-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages 1 wk-90 yrs will be screened and enrolled in this study to determine if they have a clinically-relevant food allergy. If so, they could be eligible for interventional clinical trials in the future.

Brief summary: This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.


Eligibility criteria: Inclusion Criteria:

* Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.

Exclusion Criteria:

* Any individual who does not consent
* Any individual who is currently taking oral steroids
* Any individual with moderate to severe asthma (FEV1\<80%)

Primary outcomes:
measure: Outcome of standardized food challenges
timeFrame: 1 year
Secondary outcomes:
measure: skin testing will occur to evaluate food allergen responses
timeFrame: 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: The Sean N. Parker Center for Allergy and Asthma Research, Stanford University
state: California
Study officials:
affiliation: Stanford University, SNP Center for Food Allergy and Asthma Research
name: Sayantani Sindher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purington N, Chinthrajah RS, Long A, Sindher S, Andorf S, O'Laughlin K, Woch MA, Scheiber A, Assa'ad A, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Galli SJ, Desai M, Nadeau KC. Eliciting Dose and Safety Outcomes From a Large Dataset of Standardized Multiple Food Challenges. Front Immunol. 2018 Sep 21;9:2057. doi: 10.3389/fimmu.2018.02057. eCollection 2018.
Clinical trial NCT05405192: Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
Official title: Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Gestational Trophoblastic Neoplasia
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2022-06-06
Enrollment: 0
Sex: FEMALE
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 see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).


Eligibility criteria: Inclusion Criteria:

1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
2. Female patients \>18 years old.
3. Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
4. Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).

Exclusion Criteria:

1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
2. Participant must not be simultaneously enrolled in any interventional clinical trial.
3. Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.

Primary outcomes:
measure: Proportion of patients with successful normalization of beta hCG
timeFrame: Up to 24 months
Secondary outcomes:
measure: Proportion of patients with objective response rate (ORR)
timeFrame: Up to 25 months
measure: Number of Participants with treatment related-adverse events
timeFrame: Up to 25 months
measure: Progression-free survival (PFS)
timeFrame: Up to 48 months
measure: Overall survival (OS)
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Marilyn Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03447392: Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Official title: Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Patient Education
Chinese Medicine
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 134
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.

Detailed description: Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of Integrated Traditional and Western Medicine is not known. The investigators hypothesized that a patient discharge education of Integrated Traditional and Western Medicine program would improve clinical outcomes in patients with chronic heart failure.

Eligibility criteria: Inclusion Criteria:

* Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction\<0.40).

Exclusion Criteria:

* CKD4 and CKD5

Primary outcomes:
measure: total number of days hospitalized
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: The Second Clinical College, Guangzhou University of Chinese Medicine
name: Xu ZOU
role: STUDY_CHAIR
References:
Clinical trial NCT00500292: A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
Official title: A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal
Cancer
Keywords: colorectal
cancer
zactima
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 109
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 determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.


Eligibility criteria: Inclusion Criteria:

* Progression on or following treatment for metastatic colorectal cancer
* Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
* Have World Health Organisation (WHO) performance status 0-2 and life expectancy \>12 weeks

Exclusion Criteria:

* Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
* Previous adjuvant therapy with irinotecan within 12 months of randomisation
* More than one prior course of chemotherapy for treatment of metastatic colorectal cancer

Primary outcomes:
measure: Number of Patients With an Objective Disease Progression Event
timeFrame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille Cedex
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Hospitalet deLlobregat
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT00144092: HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Official title: High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Grade Lymphoma
Keywords: autologous and allogeneic stem cell transplantation
low grade lymphoma
mantle cell
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.

Detailed description: Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.

Eligibility criteria: Inclusion Criteria:

* indolent histology lymphomas after relapse 1 or 2 LVEF \> 50% Creatinine \< 150 umol/L bilirubin \< 30 umol/L wbc \>3.5X10\^9/L platelets \>100X10\^9/L other medical condition as controlled

Exclusion Criteria:

* pregnant lactating HIV positive CNS involvement by lymphoma other malignancy

Primary outcomes:
measure: feasibility
measure: mortality
measure: overall survival
measure: event free survival
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancer Board - TBCC
name: Doug Stewart
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
Clinical trial NCT06456489: Pulse Steroid Injection in Refractory Rheumatoid Arthritis
Official title: Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Active Rheumatoid Arthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 268
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remission or low disease activity in active rheumatoid arthritis

Detailed description: Assessment of rheumatoid arthritis activity by Disease activity score DAS28, DAS28 Erythrocyte sedimentation rate (ESR), American college of rheumatology (ACR) 20, ACR 50, ACR 70 will be done at baseline and every month for 3 consecutive months for both groups.

Eligibility criteria: Inclusion Criteria:

* Refractory rheumatoid arthritis patients

Exclusion Criteria:

* Other connective tissue diseases
* Endocrine diseases such as DM and thyroid disorders

Primary outcomes:
measure: remission or low disease activity
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Univrsity
Study officials:
References: