louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01329627: Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
Official title: Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Locally Advanced HER2-negative Breast Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação Faculdade de Medicina
First posted: 2011-04-06
Enrollment: 12
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 determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* Locally advanced breast cancer diagnosed by guided core biopsy
* T \> 2 cm (any N), or any T and node positive (needle biopsy is required)
* Non-metastatic disease assessed by computed tomography and bone scintigraphy
* Histological grade 2 and Ki67 \> 15% or
* Histological grade 3 or
* Any triple negative (TN) or
* Inflammatory breast cancer (IBC)
* Normal left ventricular ejection fraction (LVEF)
* HER2-negative disease

Exclusion Criteria:

* Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
* Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
* LVEF value below institutional limits of normal
* Predominant lobular carcinoma histology
* Grade 1 tumors
* Detected or suspicious distant metastasis
* Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
* Male sex
* HER2-positive breast cancer

Primary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: 18 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: From the beginning of treatment until surgery, progression and death
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: State of Sao Paulo Cancer Institute
Study officials:
References:
Clinical trial NCT04673227: Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI)
Official title: Cytometric Immunodiagnostics of Latent Tuberculosis Infection (LTBI) and the Influence of Previous BCG Vaccination - Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: LTBI
BCG Vaccination Reaction
TB
Lead sponsor: Thomayer University Hospital
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2020-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study of the broad spectrum of population with the history of having an active TB infection or close contact with bacteriologically approved pulmonary TB

Brief summary: TB-reactive immune cells will be tested in a multiparametric flow cytometry to distinguish an immune response for antigens of Mycobacterium spp. in TB disease/latent infection or a reaction after BCG vaccine.

Detailed description: The goal of this project is the verification of current cytometric panel of detection antibodies in a wider panel of stimulative immunodominant antigens for CD4+ and CD8+ T cells in combination with adjuvants 2 in a in vitro activating test.

Eligibility criteria: Inclusion Criteria: active TB, contact with TB infection in previous 3 months before the study

-

Exclusion Criteria:

* HIV positive patients

Primary outcomes:
measure: Peer-review publication of results of our study
timeFrame: 2 years
Secondary outcomes:
measure: Creation of new diagnostic tool and his comparision with existing IGRA test (QTF-GP and TST)
timeFrame: 2 years
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty of Science
city: Prague
country: Czechia
facility: Thomayer Hospital
Study officials:
References:
Clinical trial NCT03417427: A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML
Official title: A Multicenter Randomized Control Clinical Trail of Evaluating Effect of Demethylation Drug Combined With Chemotherapy in Patients With Intermediate-risk AML After Hematological Complete Remission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leukemia, Myeloid
Keywords: acute myeloid leukemia
Intermediate-risk
demethylation drug
complete remission
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is often impossible to find therapeutic target in intermediate-risk AML, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. Both of them will result in eliminating MRD in patients with AML. The investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML patients with intermediate-risk factors after hematological complete remission. Efficacy will be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or consolidation chemotherapy, those with continuous positive MRD should be considered as candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after follow-up every 3 months. It will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the AML patients with intermediate-risk factors.


Eligibility criteria: Inclusion Criteria:

* AML patients with normal heart, lung, liver and renal function, or without serious infection. ECOG score is below 2

Exclusion Criteria:

* AML patients with abnormal heart, lung, liver and renal function, or with serious infection. ECOG score is over 2

Primary outcomes:
measure: Minimal residual disease
timeFrame: 1 month
Secondary outcomes:
measure: Overall survival
timeFrame: 3 months
measure: Relapse free survival
timeFrame: 3 months
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03113227: Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery
Official title: Diagnostic Accuracy of Posterior Cervical Angle and Cervical Length in Prediction of Successful Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Keywords: induction of labor
Bishop score
posterior cervical angle
cervical length
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.

Detailed description: Seventy patients indicated for induction of labor will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, transvaginal ultrasound will be done to assess the posterior angle and the length of the cervix. Then vaginal examination will be done to measure the Bishop score. Analysis will be done to identify the best predictor of successful induction of labour.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 35 and 42
* Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
* The fetus is living
* Cephalic presentation

Exclusion Criteria:

* Estimated fetal weight more than 4 kilograms
* Malpresentation
* Oligohydramnios
* Polyhydramnios
* Non-reassuring non-stress test before induction of labor
* Cephalo-pelvic disproportion
* Previous operation on the cervix as cautery or cerclage
* Previous cesarean section
* Any contraindication to vaginal delivery including placenta previa
* Anomalous fetus
* Morbid obesity

Primary outcomes:
measure: Value of posterior cervical angle
timeFrame: At around 10 minutes from admission to hospital
Secondary outcomes:
measure: Length of the cervix
timeFrame: At around 10 minutes from admission to hospital
measure: Bishop score
timeFrame: At around 30 minutes from admission to hospital
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Eman Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Adwy AM, Sobh SM, Belal DS, Omran EF, Hassan A, Saad AH, Afifi MM, Nada AM. Diagnostic accuracy of posterior cervical angle and cervical length in the prediction of successful induction of labor. Int J Gynaecol Obstet. 2018 Apr;141(1):102-107. doi: 10.1002/ijgo.12425. Epub 2018 Jan 18.
Clinical trial NCT00211627: Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Official title: Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Snoring
Sleep Apnea Syndromes
Lead sponsor: Miller, Chipp St. Kevin, M.D.
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

Detailed description: The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.

Eligibility criteria: Inclusion Criteria:- 18 yrs. of age or greater

* generally good health
* Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development )
* Simple snoring( documented by observer) or mild sleep apnea RDI \< 15 ( documented by polysomnogram)
* Subject must have a concerned observer to assess of sleep and snoring behavior during trial period

Exclusion Criteria:- Presence of Wisdom teeth (third molars)

* active oral disease
* acute illness
* BMI (body mass index) \> 30

Primary outcomes:
measure: Reduction/Elimination of snoring behavior
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Chipp St. Kevin Miller M.D.
state: California
Study officials:
affiliation: St. Johns Health Center
name: Chipp K. Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486173: Early Nutrition and Neurological Development of Very Preterm Infants
Official title: Early Nutrition and Neurological Development of Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Premature, Diseases
Infant Nutrition Disorders
Development; Delayed, Mental
Keywords: PUFA
Iron
Neurological development
Premature infant
Lead sponsor: Lapillonne, Alexandre, M.D.
Sponsor class: INDIV
First posted: 2011-12-06
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2

Brief summary: The main goal of this study is to determine the association between:

* the quantity of mother's milk and duration of breastfeeding
* the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA \< 32 weeks.


Eligibility criteria: Inclusion criteria:

* infants with a gestational age \< 32 weeks already included in the EPIPAGE2 study
* agreement of parents

Exclusion criteria:

* death during hospitalisation

Primary outcomes:
measure: Neurological development at 2 years of age
timeFrame: 3 years
Secondary outcomes:
measure: Nutritional status at time of discharge
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker hospital
state: Ile-de-France
Study officials:
affiliation: Alexandre Lapillonne
name: Alexandre Lapillonne, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01473173: Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 59
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study are:

* To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
* To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old (inclusive)
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
* Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg, 45 beats per minute ≤ pulse rate ≤ 95 beats per minute)
* Non-smokers or non-users of nicotine-containing products for at least 3 months

Exclusion Criteria:

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
* History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
* History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori

Primary outcomes:
measure: To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255873: Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
Official title: Effects of L-Carnitine Supplementation on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Diet
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started ketogenic diet only.


Eligibility criteria: Inclusion Criteria:

* All infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start KD.

Exclusion Criteria:

* Patients with intolerance or non-compliance to ketogenic diet therapy.
* Patients for epilepsy surgery or vagal nerve stimulation.
* Children with history of previous abdominal operations.
* Children with history of GI diseases affecting GI motility before starting KD.
* Children with tube feeding or feeding gastrostomy or jejunostomy.

Primary outcomes:
measure: Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD).
timeFrame: At time of enrollment and 3 months of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine-Ain Shams University
state: Abbasia
Study officials:
affiliation: Professor of pediatrics, Faculty of Medicine, Ain shams University
name: May F Nassar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06327373: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
Official title: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.


Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years
* Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
* Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity \[TRV\] \>2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation \<90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to \<88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).

Exclusion Criteria:

* Daily supplemental oxygen use
* Inability to provide informed consent

Primary outcomes:
measure: Change daily hypoxemia burden
timeFrame: Weeks 1, 2, and 3
Secondary outcomes:
measure: Change in six minute walk distance
timeFrame: Weeks 1 and 3
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Weeks 1 and 3
Other outcomes:
Locations:
city: Durham
country: United States
facility: Davita Durham East
state: North Carolina
city: Durham
country: United States
facility: Davita Durham Downtown
state: North Carolina
city: Durham
country: United States
facility: Davita Research Triangle Park
state: North Carolina
city: Durham
country: United States
facility: Davita Durham Regional
state: North Carolina
city: Durham
country: United States
facility: Davita Durham West
state: North Carolina
city: Durham
country: United States
facility: Davita Bull City
state: North Carolina
city: Durham
country: United States
facility: Davita Durham Southpoint
state: North Carolina
city: Durham
country: United States
facility: Davita Hope Valley
state: North Carolina
city: Henderson
country: United States
facility: Davita Vance County
state: North Carolina
city: Henderson
country: United States
facility: Davita Kerr Lake
state: North Carolina
city: Roxboro
country: United States
facility: Davita Roxboro
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel Edmonston, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03050073: Choroidal Thickness Association With Primary Angle Closure
Official title: Choroidal Thickness Association With Primary Angle Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Thickness
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 42
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: Every patient consulting for glaucoma or not with primary angle closure

Brief summary: A chinese study shows that chinese population eyes with a primary angle closure have a greater choroidal thickness than normal eyes.The increase of choroidal thickness would be associated to this primary angle closure.

Detailed description: Usual ophtalmic consultation for glaucoma with primary angle closure

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Primary angle closure confirmed by gonioscopy
* interpretable images for choroidal thickness measure
* interpretable images by Ultra Bio Microscopy (UBM)

Exclusion Criteria:

* Acute crisis for angle closure
* Rethinopathy (diabetic or hypertensive)
* Histories of intra-eye surgery
* Great myopia
* Hypermetropia
* retinal pathology

Primary outcomes:
measure: change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source)
timeFrame: Day 1 Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: CRC
name: Hélène BEAUSSIER, Pharm-D
role: STUDY_DIRECTOR
References: