louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04758078: Inhaled Budesonide in Transient Tachypnea of the Newborn
Official title: Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 34
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.

Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn


Eligibility criteria: Inclusion Criteria:

* Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
* Diagnosis of transient tachypnea of the newborn
* The need for Continuous positive airway pressure (CPAP) \>6 hours to obtain the oxygen saturation \>92%

Exclusion Criteria:

* Meconium aspiration syndrome;
* Respiratory distress syndrome
* Congenital heart Disease
* Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
* Pneumonia by chest x-ray
* Suspected sepsis/bacteremia
* Prenatal steroids

Primary outcomes:
measure: Assessment of respiratory distress
timeFrame: within 48 hours
Secondary outcomes:
measure: Assessment of time to spontaneous breathing
timeFrame: with 48 hours
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Sirin Mneimneh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03481478: Detecting Occult Proximal Humeral Neck Fractures Through CT and MRI Tests of Patients With Greater Tuberosity Fractures
Official title: Third Hospital of Hebei Medical University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humeral Greater Tuberosity
Humeral Fractures/ Proximal
Fractures/ Occult
Keywords: occult
proximal humeral neck fractures
greater tuberosity
shoulder dislocation
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient demographics, comorbidities, injury mechanisms and other variables were recorded and calculated for each case.

Brief summary: Patients with greater tuberosity fractures is becoming increasingly common, as is the number of cases of humeral surgical neck fractures. This study investigated the relationship between size of greater tuberosity fragment and occurrence of humeral surgical neck fractures by using CT or MRI tests.

Detailed description: Some humeral surgical neck fractures can be detected through X-ray of shoulder in patients with greater tuberosity fractures. However, some fractures can not be find through conventional X-ray in such patients unless broader CT or MRI tests are required to confirm diagnoses of humeral surgical neck fractures.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older with greater tuberosity fractures and shoulder dislocation/ or not who were acute injured were included

Exclusion Criteria:

* Patients with ipsilateral previous proximal humeral fractures and obviously proximal humeral fractures were excluded。

Primary outcomes:
measure: Humeral surgical neck fractures can be detected through CT/MRI.
timeFrame: 31/12/2018
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Guo Junfei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01393678: Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
Official title: A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Liver Disease
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic hepatitis by biopsy
* Patients over 20, under 65 years of age.
* Patients with abnormal transaminase value.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
* Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
* Toxic hepatitis, alcoholic hepatitis.
* Total bilirubin value more than 3.0 mg/dl.
* Albumin value less than 3.0 g/dl.
* Patients who participating in other study about drug.

Primary outcomes:
measure: ALT(Alanine Aminotransferase)
timeFrame: 10 weeks
Secondary outcomes:
measure: AST (Aspartate Aminotransferase)
timeFrame: 10 weeks
measure: g-GT (γ-glutamyl transpeptidase)
timeFrame: 10 weeks
measure: Total bilirubin
timeFrame: 10 weeks
measure: PLT (Platelet)
timeFrame: 10 weeks
measure: Total cholesterol
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Seoul, Seongdong-gu,
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University
name: Minho Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523078: Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
Official title: Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing reconstruction surgery after mastectomy at an academic center

Brief summary: This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed invasive breast carcinoma
* Women who underwent mastectomy and breast reconstruction
* Good performance status (ECOG 0-1)

Exclusion Criteria:

* Recurrent breast cancer
* History of ipsilateral breast irradiation

Primary outcomes:
measure: Change from baseline of Breast-Q questionnaire score
timeFrame: Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
measure: Change from baseline of Breast-Q questionnaire score
timeFrame: Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
measure: Change from baseline of Breast-Q questionnaire score
timeFrame: 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Secondary outcomes:
measure: Reconstruction complications
timeFrame: within 1 year after last reconstruction procedures (plus 8 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Korea
Study officials:
References:
citation: Chung SY, Chang JS, Shin KH, Kim JH, Park W, Kim H, Kim K, Lee IJ, Yoon WS, Cha J, Lee KC, Kim JH, Choi JH, Ahn SJ, Ha B, Lee SY, Lee DS, Lee J, Shin SO, Lee SW, Choi J, Kim MY, Kim YJ, Im JH, Suh CO, Kim YB. Impact of radiation dose on complications among women with breast cancer who underwent breast reconstruction and post-mastectomy radiotherapy: A multi-institutional validation study. Breast. 2021 Apr;56:7-13. doi: 10.1016/j.breast.2021.01.003. Epub 2021 Jan 20.
citation: Chang JS, Song SY, Oh JH, Lew DH, Roh TS, Kim SY, Keum KC, Lee DW, Kim YB. Influence of Radiation Dose to Reconstructed Breast Following Mastectomy on Complication in Breast Cancer Patients Undergoing Two-Stage Prosthetic Breast Reconstruction. Front Oncol. 2019 Apr 9;9:243. doi: 10.3389/fonc.2019.00243. eCollection 2019.
Clinical trial NCT01849978: Enhancing Exercise in Breast Cancer Survivors
Official title: Enhancing Exercise in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
survivor
exercise
physical activity
strenuous exercise
moderate exercise
enjoyable exercise
enjoy exercise
breast cancer survivor
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 81
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 study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.


Eligibility criteria: Inclusion Criteria:

* no health restrictions on performing moderate to strenuous physical activity
* must be 18 years or older and able to give legal consent

Exclusion Criteria:

* may not be participating in another research study regarding exercise
* restrictions on performing physical activity

Primary outcomes:
measure: change in number of minutes of moderate to strenuous physical activity
timeFrame: baseline, 1 month and 3 months
Secondary outcomes:
measure: changes in joy and satisfaction with physical activity
timeFrame: baseline, 1 month, and 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Isaac Lipkus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850871: Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies
Official title: Evaluation of Ceftazidime-avibactam Plus Aztreonam in Patients Infected by MBL-producing Enterobacterales and CRISPR/Cas9-based Strategy for Curing Drug-resistant Genes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carbapenem-Resistant Enterobacteriaceae Infection
Keywords: carbapenem resistance
Enterobacteriaceae
CRISPR/Cas9
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 427
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against Metallo-β-lactamases (MBL) producing Enterobacterales in vivo. The investigators then use CRISPR/Cas9 technology to remove Enterobacteriaceae bacteria resistance and virulence genes

Detailed description: Clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; Bacterial species names will be identified and drugs sensitivity will be detected; For patients with bloodstream infection of MBL-producing Enterobacterales, ceftazidime-avibactam (CAZ-AVI) was administered at the dose of 2.5 g every 8 hours and aztreonam (ATM) at the dose of 2 g every 8 hours.

The primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (LOS) after bloodstream infection diagnosis. Cox regression analysis, including a propensity score (PS) for receiving CAZ-AVI plus ATM, was conducted to assess the primary and secondary outcomes. The CRISPR/Cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of Enterobacteriaceae in the mouse intestinal colonization model.

Eligibility criteria: Inclusion Criteria:

* Subjects clinically suspected of infection caused by Enterobacterales
* Subjects with bloodstream infection by MBL-producing Enterobacterales

Exclusion Criteria:

* Infections caused by viruses, fungi, atypical pathogens, and other non-Enterobacteriaceae bacteria
* subjects who are unwilling to enter the research group

Primary outcomes:
measure: 30-day all-cause mortality
timeFrame: two years
measure: clinical failure at day 14
timeFrame: two years
measure: length of stay after diagnosis
timeFrame: two years
Secondary outcomes:
measure: Positive rate of Metallo-β-lactamases (MBL) producing Enterobacterales
timeFrame: two years
Other outcomes:
measure: Curation index as assessed by MBL producing Enterobacterales compared with MBL negative Enterobacterales.
timeFrame: two years
Locations:
city: Jinan
country: China
facility: Mingju Hao
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Jiasheng Zhang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05122871: Scape Room With High Fidelity Simulators
Official title: Scape Room With High Fidelity Simulator: Results in the Learning and Satisfaction of Nursing Degree Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of the present study is assess the efficcacy in the acquisition of knowledge and practical skills of a scape room with high definition simulators.

An experimental trial will be carried out in which the students of the intervention group will receive practical training on newborn care in the delivery room through the development of a scape room with high-fidelity simulators. The control group students will receive practical training only with the use of high-fidelity simulators. The participants of both groups will previously receive a theoretical training of 10 hours. Knowledge acquisition and student satisfaction with both methodologies will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Nursing degree students of University of Extremadura

Exclusion Criteria:

* 1st year nursing degree students
* Nursing degree students of other universities

Primary outcomes:
measure: Knowledge test
timeFrame: 1 month after training session
Secondary outcomes:
measure: Satisfaction likert scale
timeFrame: 1 month after training session
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Cristina Franco Antonio
Study officials:
affiliation: University of Extremadura
name: Cristina Franco Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03960671: Therapeutic Drug Monitoring of Anxiolytics in Children
Official title: Therapeutic Drug Monitoring of Anxiolytics in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anxiolytics
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.


Eligibility criteria: Inclusion Criteria:

* Anxiolytics was used for therapeutic purposes;
* Age:≤18 years;
* Patients with therapeutic concentration monitoring of anxiolytics.

Exclusion Criteria:

* Patients without therapeutic concentration monitoring of anxiolytics;
* The blood concentrations of the patient was not approved by the quality control center
* Use foods or products that inhibit or induce CYP 3A activity.

Primary outcomes:
measure: Plasma drug concentration
timeFrame: Through study completion, an average of 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT06322771: Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal
Official title: Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Keywords: Refusal
Clinical trial
Factors
Reasons
Pregnancy
Pre-eclampsia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 830
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women identified and eligible to participate in the RANSPRE trial within the Port-Royal maternity ward and having their T1 ultrasound scan within the maternity ward will be included.

Brief summary: The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

Detailed description: 1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
2. Comparison of demographic characteristics between the two groups

   * Group 1: women accepting to participate in RCT
   * Group 2: women refusing to participate in RCT
3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Eligibility criteria: Inclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial.

Any pregnant woman is eligible if:

* monofetal pregnancy
* between 11 and 14 weeks
* legal age
* health insurance coverage

Exclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial. A history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.

Primary outcomes:
measure: Factors associated with women's refusal
timeFrame: Day 1
Secondary outcomes:
measure: Number of acceptations
timeFrame: Day 1
measure: Number of refusals
timeFrame: Day 1
measure: Demographic characteristics
timeFrame: Day 1
measure: Questionnaire "acceptance"
timeFrame: Day 1
measure: Questionnaire "refusal"
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Port-Royal Maternity
state: IDF
Study officials:
affiliation: Port-Royal Maternity - APHP
name: Yoann Athiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830271: Vicryl Plus and Monocryl Plus in Breast Surgery
Official title: Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Keywords: surgical site infection
wound complications
suture
antiseptic
wound closure
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2009-01-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery

Exclusion Criteria:

* patients unable to give consent or comply with follow up
* patients undergoing surgery for benign disease
* patients with inflammatory cancers or skin ulceration
* patients having neo-adjuvant chemotherapy or radiotherapy
* patients with known allergy to triclosan antiseptic
* patients with immune deficiency diseases

Primary outcomes:
measure: reduction of surgical site infection
timeFrame: 6-7 months
Secondary outcomes:
measure: estimation time in hospital and return to work numbers of haematomas and seromas
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale NHS Trust
state: Wales
Study officials:
References: