louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04585256: Trendelenburg Positioning and External Cephalic Version Outcome
Official title: The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breech Presentation of Fetus With Successful Version
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.

Detailed description: This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.

The women that are eligible for participation will receive a thorough explanation and will sign informed consent.

Eligibility criteria: Inclusion Criteria:

* Women interested in having external cephalic version at a gestational age of 37+0/7 or more.

Exclusion Criteria:

* Age 18 and under.
* Women with a body mass index 35 or higher.
* Women with a previous cesarean section.
* Women with premature rupture of membranes.
* Women with vaginal bleeding.
* Women with a previously failed external cephalic version.

Primary outcomes:
measure: External cephalic version success
timeFrame: Up to 10 minutes from the beginning of external cephalic version.
Secondary outcomes:
measure: Pain
timeFrame: Up to 2 hours from the beginning of external cephalic version.
measure: Placental abruption
timeFrame: Up to 1 week from the beginning of external cephalic version.
measure: Vaginal delivery
timeFrame: Up to 4 weeks from the beginning of external cephalic version.
measure: Cesarean delivery
timeFrame: Up to 4 weeks from the beginning of external cephalic version.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05737056: Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians
Official title: Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Purpura
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified by the Medical Information Department of each site. The study will be conducted on patients who have been managed for rheumatoid purpura within the last two years at one of the three participating centers.

Brief summary: The main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.

Detailed description: Secondary objectives The secondary objective is to assess general practitioners current knowledge and practice of the condition and potential barriers to monitoring and follow-up by general practitioners.

Conduct of research Children diagnosed with rheumatoid purpura within the past 2 years at the 3 participating sites will be included in the study if parental authority holders do not object.

Patients will be identified through the Medical Information Department of each hospital.

Parents will be contacted - first by mail, then by phone - to request permission to collect the child's medical data from medical records, and to retrieve information on the surveillance and follow-up of the disease by general practitioners up to two years after diagnosis.

Eligibility criteria: Inclusion Criteria:

* Underaged patient diagnosed with rheumatoid purpura during a visit to the pediatric emergencies of Mulhouse, Colmar and Strasbourg
* No objection to the study from the two holders of parental authority

Exclusion Criteria:

- Patient followed in the context of a genetic or malformative pathology, an immune deficiency, or a cancer

Primary outcomes:
measure: Compliance with the recommendations for the management of rheumatoid purpura
timeFrame: Up to two years after hospital discharge
Secondary outcomes:
measure: Knowledge assessment questionnaire regarding rheumatoid purpura
timeFrame: At the beginning of the study
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
Study officials:
References:
Clinical trial NCT00225056: Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Official title: Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Oncology Specialties, Alabama
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 43
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.


Eligibility criteria: Inclusion Criteria:

* must have metastatic breast cancer
* must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
* must have measurable or evaluable disease
* ECOG of 0-1
* patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
* must have adequate organ function
* must be at least 19 years of age
* peripheral neuropathy less than or equal to grade 1
* must have voluntarily signed informed consent
* patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled

Exclusion Criteria:

* patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
* patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
* known uncontrolled existing coagulopathy
* patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
* use of other investigational agents in the last 28 days
* pregnant or lactating women
* patients who are known HIV positive
* patients with life expectancy of less than 3 months
* sexually active patients unwilling to practice reliable contraception during the study

Primary outcomes:
measure: Overall clinical benefit rate
Secondary outcomes:
measure: safety and tolerability
measure: evaluate QOL
measure: determine progression free survival
measure: determine time to response and overall survival
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
Study officials:
affiliation: Oncology Specialties, PC
name: John M Waples, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163656: Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
Official title: A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: Neonate
Laryngoscopes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 66
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Detailed description: We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo elective surgery at CHOP
2. American Society of Anesthesiologists (ASA) Physical Status I or II
3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

Exclusion Criteria:

1. At known or anticipated high risk for aspiration pneumonia
2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
3. Emergency surgical procedure
4. Patients with preoperative airway pathology or stridor -

Primary outcomes:
measure: Time to Tracheal Intubation
timeFrame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: John Fiadjoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03451656: Prospective System Analysis of the Seasonal Influenza Virus Transmissions and Evolution in the City of Basel Basel
Official title: Prospective System Analysis of Seasonal Influenza - Virus Transmission and Evolution in Basle Town
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric or adult patients fulfilling the WHO-definition of an influenza-like illness and living at Basel.

Brief summary: The project aims to use epidemiological tools to understand the transmission and evolution of influenza viruses at an individual and population level within a small-scale city (Basel) through a combination of experimental, clinical, and mathematical advances. Investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.

Detailed description: Samples will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (PCR) and to determine colonization rates with Staphylococcus aureus and Streptococcus pneumonia. All samples except the first naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in batches. Each influenza virus isolate will be sequenced using a "whole genome sequencing" approach. The viral transmission and evolution will be analysed using whole genome data for a detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and geographical data will be incorporated into the phylogenetic model.

Eligibility criteria: Inclusion Criteria:

* Each pediatric or adult patient, which fulfill the World Health Organization (WHO) definition of Influenza like illness.
* The case definition includes an acute respiratory infection with coughing, fever ≥38°C, and start of symptoms within the last 10 days.
* Presentation of the patient with influenza-like illness on the emergency ward of the University Hospital Basel or the University Children Hospital of both Basel or a collaborating private practise.

Exclusion Criteria:

- Case definition for influenza like illness is not fulfilled

Primary outcomes:
measure: Similarity of Influenza viruses
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Microbiology; University Hospital Basel
name: Adrian Egli, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04602156: US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Official title: Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Keywords: Percutaneous cholecystostomy
ultrasound-guided
interventional radiology
Trocar
Seldinger
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy

Detailed description: This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.

Eligibility criteria: Inclusion Criteria:

* All patients requiring PC, regardless of the underlying cause.
* Signed informed consent form

Exclusion Criteria:

* Age \<18 years or \>100 years
* The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician
* Severe uncontrollable coagulopathy

Primary outcomes:
measure: Technical success
timeFrame: At the end of the procedure
measure: Procedure-related complications
timeFrame: 3 months
Secondary outcomes:
measure: Duration of the procedure
timeFrame: Intraprocedural
measure: Intraprocedural pain
timeFrame: End of the procedure
measure: Post-procedural pain
timeFrame: 12 hours
measure: Clinical success
timeFrame: 72 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
affiliation: ATTIKO University Hospital
name: Stavros Spiliopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05167656: Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
Official title: Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.


Eligibility criteria: Inclusion Criteria:

* Unilateral temporomandibular pain for more than one month.
* Older than eighteen.
* No previous treatment to temporomandibular pain in the last 3 months.
* Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Exclusion Criteria:

* Patients with cervical or cranial trauma or whiplash.
* Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
* Diagnosed of any vascular or metabolic disease.
* Previous cervical or temporomandibular surgery.
* Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Secondary outcomes:
measure: Change in pain pressure threshold
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
measure: Change in range of movement of the temporomandibular joint
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
measure: Change in quality of life
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
measure: Change in disability
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
measure: Change in anxiety
timeFrame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
References:
Clinical trial NCT06968156: The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19
Official title: The Effect of Monocyte Values Accompanied by Lymphopenia on the Prognosis of Patients Diagnosed With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Lymphopenia Due to COVID-19
Monocyte
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted among patients admitted to the intensive care unit of a tertiary hospital.

Brief summary: Recent studies have shown that lymphopenia with cytokine storm syndrome is frequently found in COVID-19 patients. These features may suggest that the modified immune system plays a key role in determining disease progression. Lymphopenia or lymphocytopenia is a condition in which the number of lymphocytes in the blood is low. Although T cells can be increased at the onset of COVID-19, these patients tend to have low lymphocyte counts, which is associated with increased COVID-19 severity. Thus, individuals who died of COVID-19 have been shown to have significantly lower lymphocyte levels than survivors. There is evidence that myeloid cells play a role in the pathophysiology of coronavirus infection, either directly as virus targets or indirectly as effectors of cytokine release syndrome. Monocytes are innate hematopoietic cells that maintain vascular homeostasis and provide early responses to pathogens during acute infections. The role of monocytes and macrophages in the resolution of inflammation has also been emphasized as an important component of the response to SARS-CoV-2. Accordingly, it was investigated whether the change observed in blood monocyte levels was an effective parameter in the prognosis process in Covid-19 cases with lymphopenia, considering that monocyte levels could be useful as a guide in the course of the disease.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Male and female of both genders
* Admitted to the intensive care unit
* Diagnosed with Covid-19 with lymphopenia
* Patients with confirmed COVID-19 diagnosis in polymerase chain reaction (PCR) tests performed on nasopharyngeal swab samples

Exclusion Criteria:

* Those with a negative PCR test
* Aged 18 and under

Primary outcomes:
measure: prognostic course, rate of mortality
timeFrame: through study completion, an average of 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT04992156: Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET
Official title: A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.


Eligibility criteria: Inclusion Criteria:

1. Female patients aged 18-70 years.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
4. HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
5. Palbociclib treatment of metastatic breast cancer for at least one cycle.
6. Available medical history.

Exclusion Criteria:

1.Incomplete medical history.

Primary outcomes:
measure: PFS
timeFrame: Through study completion, an expected average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Biyun Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu C, Hu S, Xu X, Zhang Y, Wang B, Song S, Yang Z. Evaluation of tumour heterogeneity by 18F-fluoroestradiol PET as a predictive measure in breast cancer patients receiving palbociclib combined with endocrine treatment. Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.