louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00871559: A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies
Official title: A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-03-30
Enrollment: 83
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: The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older
2. Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit.
3. Patients with measurable or non-measurable disease
4. At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM)
5. At least 4 weeks must have elapsed since the last major surgery
6. For women of childbearing potential, a negative urine pregnancy test at the screening visit
7. Willingness to use adequate contraception during the full course of the study. Systemic hormonal contraceptive agents are excluded
8. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
9. Able to read, understand and willing to sign the informed consent form

Exclusion Criteria:

1. Medical history of myocardial infarction or cardiomyopathy
2. Unstable angina
3. NYHA class II - IV congestive heart failure
4. Patients under treatment with more than 2 antihypertensive medications
5. History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant GI hemorrhage within 6 months of study drug administration
6. Diabetic retinopathy
7. Patients requiring anticoagulation
8. Hypersensitivity to doxycycline or related compounds

Primary outcomes:
measure: Safety and tolerability
timeFrame: 18 months
Secondary outcomes:
measure: Preliminary evidence of antitumor activity
timeFrame: 18 months
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT05156359: Idiopathic Scoliosis and Orthodontic Treatment
Official title: Idiopathic Scoliosis and Orthodontic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
Orthodontic Treatment
spinal dysmorphism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children (age ≥ 12 years) with idiopathic scoliosis confirmed by X-ray.

Brief summary: Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.

The aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.


Eligibility criteria: Inclusion criteria:

* Adult and child (age ≥ 12 years)
* Be carriers of idiopathic scoliosis confirmed by X-ray.
* Have reached bone maturity (Risser 4 and more)
* Adult who has not expressed, after information, the reuse of his data for the purposes of this research
* - Child and Holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research

Exclusion criteria:

* Refusal to participate in the study
* Association with another orthopedic pathology
* Adult patients under guardianship or crater or under the protection of justice

Primary outcomes:
measure: Determination of the frequency of wearing orthodontic treatment in idiopathic scoliosis adolescents, and compare it with that of adolescents without spinal dysmorphism.
timeFrame: Files analysed retrospectively from January 01, 2020 to August 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02621359: A Two Week Nitazoxanidebased Quadruple Regimen
Official title: A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyspepsia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Detailed description: Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth \[11\]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Eligibility criteria: Inclusion Criteria:

* Patients with helicobacter infection.
* in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion Criteria:

* Patients under 18 or over 65 years of age.
* Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
* pregnancy/lactation
* having contraindication or allergy to any of the study drugs

Primary outcomes:
measure: Number of patients with eradicated helicobacter
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tropical medicine dept.-Tanta university hospital
Study officials:
affiliation: Tropical medicine-Tanta university hospital
name: Sherief Abd-Elsalam, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029859: Sleep Apnea, Obesity and Pregnancy
Official title: Sleep Apnea, Obesity and Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: pregnancy (after 30 weeks of amenorhea)
obesity (BMI>35)
sleep apnea syndrom
preeclampsy
intrauterine growth restriction
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Main objective:

Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .

Secondary objectives :

* Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
* Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
* Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.

Material and methods

Characteristics of the study:

* Interventional biomedical research
* Prospective Multicenter nonrandomized study

Flow chart

* Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
* Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
* As recommended in France, the main test results during the pregnancy follow-up will be recorded.
* At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
* Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
* In case of proven OSA patients will be offered an appropriate care by today's standards.
* Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.


Eligibility criteria: Inclusion Criteria:

* BMI \>35
* Pregnancy after 30 Weeks of amenorhea
* Age \> 18
* Signed consentment
* Nationnal Health Program affiliation

Exclusion Criteria:

* Twin or more pregnancy
* Imprecise term
* Artificial insemination with donor gametes
* Proved thrombophilia
* chronic renal failure
* Previously treated (with CPAP) obstructive sleep apnea syndrom

Primary outcomes:
measure: Sleep apnea syndrom prevalence
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Le Havre
country: France
facility: Le Havre Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Loic Marpeau, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00897559: Study of Bone Marrow Samples From Patients With Acute Leukemia
Official title: Identifying the Genetic Basis of Adult AMKL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute megakaryoblastic leukemia (M7)
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Acute Leukemia

Brief summary: RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow samples from patients with acute leukemia.

Detailed description: OBJECTIVES:

* To perform high throughput sequencing of a set of megakaryocyte specific transcription factors, tyrosine kinases, and Src kinases in DNA isolated from bone marrow specimens of adults with acute megakaryoblastic leukemia (AMKL).
* To assay the ability of Src kinase inhibitors (SU6656, dasatinib) to induce differentiation of AMKL blasts in these patients.

OUTLINE: DNA from previously collected bone marrow samples are sequenced to analyze genes associated with transcription factors (GATA1, GATA2, SCL, FOG-1, ETS1, ETS2, ERG, FLI-1, GABP, HOXA11, NF-E2, and RUNX1), tyrosine kinases (JAK2, JAK3, and c-MPL), and Src family kinases (LYN, FYN, and HCK) and compared with control DNA. Using bioinformatics, gene alterations are compared to known polymorphisms and subsequent changes in the amino acid sequence of the encoded protein. Subsequent assays assess the effect on proliferation and differentiation and in vitro studies evaluate the consequences of mutations on transcription factor and kinase activity abilities. The effect of SU6656 and dasatinib on cell death and polyploidization is evaluated by flow cytometry and compared with control DNA.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of adult acute megakaryoblastic leukemia
* Archived bone marrow specimens from the ECOG tissue repository

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of gene mutations with adult acute megakaryoblastic leukemia (AMKL)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: John Crispino, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02426359: Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Atopic Dermatitis
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-24
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: This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged 18 or older
2. Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
3. Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits

Exclusion Criteria:

1. Subjects who had topical treatment with corticosteroids within 1 week before randomization
2. Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
3. Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
4. Subjects who participated in another drug trial within 4 weeks before screening

Primary outcomes:
measure: Percentage of patients who have the IGA score of 0 or 1
timeFrame: Week 8
Secondary outcomes:
measure: Percent change from baseline on the VAS for pruritus
timeFrame: Week 8
measure: Percent change from baseline on the EASI
timeFrame: Week 8
measure: Percent change from baseline on the SCORAD
timeFrame: Week 8
measure: Percent change from baseline on the DLQI
timeFrame: Week 8
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Berlin
country: United States
state: New Jersey
city: East Windsor
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00163059: The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial To Assess The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With Treatment Refractory Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 30
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: To determine if the NMDA antagonist, CP-101,606, is effective for depression


Eligibility criteria: Inclusion Criteria:

* Primary DSM-IV diagnosis of MDD

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: MADRS
Secondary outcomes:
measure: HAM-D
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06679959: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity
Official title: A Phase I/IIa, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection, for Subcutaneous Use in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Weight Management
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection


Eligibility criteria: Inclusion Criteria:

1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

Primary outcomes:
measure: Incidence of AEs, SAEs (Safety and tolerability) of ASC30
timeFrame: Up to Day169
Secondary outcomes:
measure: Cmax of ASC30
timeFrame: Up to Day169
measure: Change From Baseline in Body Weight
timeFrame: Up to Day169
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ascletis clinical site
state: Texas
Study officials:
References:
Clinical trial NCT05283759: UZ Brussel HRMC Registry of Brugada Syndrome
Official title: UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brugada Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brugada syndrome patients diagnosed following current guidelines: (Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793-2867.) Both Brugada spontaneous type 1 and ajmaline induced will be included.

Brief summary: The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).

Detailed description: The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.

These includes:

1. demographical data: age, sex
2. antropometric data: height, weight, BMI
3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy

3) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation

Eligibility criteria: Inclusion Criteria:

* Brugada syndrome diagnosis

Exclusion Criteria:

* Other diagnosis different from Brugada syndrome

Primary outcomes:
measure: Ventricular arrhythmias
timeFrame: through study completion, an average of 10 year
measure: Atrial fibrillation
timeFrame: through study completion, an average of 10 year
measure: Death for any cause
timeFrame: through study completion, an average of 10 year
measure: Cardiovascular death
timeFrame: through study completion, an average of 10 year
measure: Genetic mutations
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel Heart Rhythm Management Center
Study officials:
References: