louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04947501: A Study of N9 Chemotherapy in Children With Neuroblastoma
Official title: N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neuroblastoma
Pediatric Cancer
Keywords: HR-NB
Neuroblastoma
pediatric cancer
21-228
Memorial Sloan Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
* HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and stage 4 in patients \>18 months old.
* No more than one prior cycle of chemotherapy.
* Age \<19 years old.
* Signed informed consent indicating awareness of the investigational nature of this treatment.

Exclusion Criteria:

* Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3.
* Inability to comply with protocol requirements.
* Pregnancy is not an issue because all patients will be pre-adolescents.

Primary outcomes:
measure: Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394001: Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy
Official title: Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II
* Planned for elective TAH with a Pfannenstiel incision

Exclusion Criteria:

Patients with the following criteria will be excluded from the study;

* ASA physical status more than II
* Body mass index (BMI)\>35 kg/m2
* Previous abdominal surgeries
* Malignancy
* Individuals with chronic pain
* A history of severe systemic disease
* A pre-existing neurological or psychiatric illness
* Known to be addict on alcohol or drugs
* Known allergy to the study drugs

Primary outcomes:
measure: Rescue analgesia time
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Patient's pain score
timeFrame: First 24 hours postoperatively
measure: The total analgesic consumption
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT00467701: Community Acquired Pneumonia in Telemark and Ostfold
Official title: Prevalence of Legionella Infections, Bacterial Etiology in Pneumonia Among Patients Admitted to Hospital,- and Risk Factors/Characteristics for These Patients.(Translated From Norwegian)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Keywords: pneumonia
Legionnaires disease
risk factors
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Sykehuset Ostfold
First posted: 2007-05-01
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with community acquired pneumonia.

Brief summary: The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia.

Detailed description: In Norway there is little knowledge of which bacterias that causes pneumonia in patients admitted to hospital. There are also few registered cases of Legionnaires disease every year, compared to our neighbour countries.

Therefore 500 patients with community acquired pneumonia admitted to Telemark hospital and Ostfold hospital in Norway will be tested by urin antigen test for the detection of Legionella pneumophila serogroup 1 and Streptococcus pneumoniae. We will also perform routine bacterial culture of sputum and culture on medium for isolation of Legionella species. A throat swab from the patients will be tested for Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis using PCR-techniques. Legionella-serology will also be performed. In addition all the included patients are invited to fill in a questionnaire in order to look for risk factors for developing community acquired pneumonia.

Eligibility criteria: Inclusion Criteria:

* Symptoms of lower airway infection and radiologic sings of pneumonia.

Exclusion Criteria:

* Age\<18
* Serious psychiatric illness
* Mentally retarded
* Hospitalized last 14 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark
state: Telemark
Study officials:
affiliation: Telemark Hospital, 3710 Skien, Norway
name: Halfrid Waage, dr.med
role: STUDY_CHAIR
References:
Clinical trial NCT05150301: Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea
Official title: Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea Outside a Level III Maternity Hospital in Alsace
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: Premature Birth
Outborn
Newborns
Gestational age
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 134
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn under 32 weeks of amenorrhea at the time of birth, born in Alsace in one of the level I, IIa, or IIb maternity hospitals, between January 1, 2016 and December 31, 2020

Brief summary: An "outborn" birth is a premature birth that occurs in an unsuitable level center at the end of the child (unlike "inborn" births).

This study aims to describe the morbidity and mortality of very premature newborns (gestational age less than 32 weeks of amenorrhea) born outside a maternity hospital of appropriate level between January 1, 2016 and December 31, 2020, and assessment of the preventable or non-preventable nature of these so-called "outborn" births.

The aim of this research is to write down the short-term mortality and morbidity of newborns born at a gestational age \<32 weeks of amenorrhea outside a level III maternity hospital in Alsace between January 1, 2016 and December 31, 2020.


Eligibility criteria: Inclusion criteria:

- Newborn under 32 weeks of amenorrhea at the time of birth, born in Alsace in one of the level I, IIa, or IIb maternity hospitals, between January 1, 2016 and December 31, 2020

Exclusion criteria:

- Fetal death in utero

Primary outcomes:
measure: Study of the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea
timeFrame: Files analysed retrospectively from January 01, 2016 to December 31, 2010 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg
name: Benoit ESCANDE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01446601: Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Official title: Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Keywords: Apnea
OSA
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypoglossal Nerve Stimulation
Sleep Disorders
Tongue
Lead sponsor: Apnex Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
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 evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.


Eligibility criteria: Inclusion Criteria:

* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy

Primary outcomes:
measure: Reduction in OSA Severity
timeFrame: from Baseline to 6 Months
measure: Long-term Reduction in OSA Severity
timeFrame: 12 months
measure: Safety Analysis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Research Institute
state: Kansas
city: Topeka
country: United States
facility: Veritas Clinical Specialties
state: Kansas
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: The Center for Sleep and Wake Disorders
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: St. Lukes Hospital
state: Missouri
city: New York
country: United States
facility: Clinilabs
state: New York
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbia
country: United States
facility: Sleep Med of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: IBAS, The Austin Hospital
state: Victoria
Study officials:
References:
Clinical trial NCT03260101: Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
Official title: A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myelogenous Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
Non Hodgkin Lymphoma (NHL)
Hodgkin Lymphoma, Adult
Lead sponsor: Cellect Biotechnology
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study. Subjects must have had one of the Hemato-Oncology Diseases to enroll into ApoGraft-01:

* Acute myelogenous leukemia (AML) \& Acute lymphoblastic leukemia (ALL)
* Non-Hodgkin's lymphoma (NHL)
* Hodgkin's lymphoma (HL)
* Intermediate, High or Very High risk Myelodysplastic syndrome (MDS)

Brief summary: This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study.

Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.


Eligibility criteria: Inclusion Criteria:

1. Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
2. Ability to comply with the requirements of the study.
3. Signed written informed consent

Primary outcomes:
measure: Incidence, grade and stage of acute GvHD and chronic GvHD
timeFrame: 18 months
Secondary outcomes:
measure: Non-relapse-related mortality
timeFrame: 18 months
measure: Proportion of subjects with disease relapse/recurrence
timeFrame: 18 months
measure: Proportion of subjects with relapse free and overall survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT05958901: Pulmonary Hypertension Observational Study
Official title: A Observational Study in Chinese Patients With Pulmonary Hypertension (PH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a observational prospective longitudinal cohort study to to establish the large PH cohort and biological database in China, including PH subjects( n= 5000) and healthy subjects (n= 5000). Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct right heart catheterization(RHC). Patients must meet all the inclusion criteria and none of the exclusion criteria. No additional investigational drugs will be applied to the patients. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure.

Brief summary: The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility criteria: Inclusion Criteria:

* PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise.
* Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years.

Exclusion Criteria:

* Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc.
* Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months.
* Eye surgery in the last three months.
* Retinal detachment myocardial infarction in the last 3 months.
* Admission to hospital for any cardiac condition in the last month.
* Heart rate over 120 beats per minute.
* Antibacterial chemotherapy for tuberculosis pregnant or breast feeding.

Primary outcomes:
measure: mean pulmonary arterial pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT04384601: Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Official title: Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Neoadjuvant Chemotherapy
Keywords: Gastric Cancer
Gastric Adenocarcinoma
Stomach Cancer, Adenocarcinoma
Chemotherapy Effect
Neoadjuvant chemotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

Detailed description: Non inferiority of SOX will be tested against FLOT. This study will be conducted at multiple center of China and will invite international centers to join it.The sponsor of this study is Ruijin Hospital and the project is supported by the Shanghai Key Laboratory of Gastric Neoplasms and Institute of Digestive Surgery, Shanghai.

Eligibility criteria: Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.
* Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases (including retroperitoneal lymph node)
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radio therapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy

Primary outcomes:
measure: Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour
timeFrame: Upto three months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Five years
measure: Disease free survival (DFS)
timeFrame: Three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Birendra K Sah, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Chen Li, PH D
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhenggang Zhu, PH D
role: STUDY_CHAIR
References:
Clinical trial NCT01255501: First in Human Study of NI-0701 in Healthy Volunteers
Official title: A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Light Chain Bioscience - Novimmune SA
Sponsor class: INDUSTRY
First posted: 2010-12-07
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Non smokers
* Able to adhere to study visits and protocol requirements

Exclusion Criteria:

* Any clinical safety laboratory measurements value \> Grade 1 on WHO Toxicity Scale
* Established or recurrent history of allergic reactions

Primary outcomes:
measure: Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
Secondary outcomes:
measure: NI-0701 Pharmacokinetic parameters in healthy volunteers
measure: NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion
measure: Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare
measure: Immunogenicity of NI-0701
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: PXL
name: John Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References: