louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05701631: Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
Official title: Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumocystis Jirovecii Pneumonia
Keywords: Computed tomography
Diagnostic tests
Pneumocystis jirovecii pneumonia
Radiomics
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to our institute with clinical suspected PCP

Brief summary: To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.

Detailed description: Retrospective study, including non-HIV patients hospitalized for suspected PCP from January 2010 to December 2022. The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model, which was then compared to a clinical-imaging model built with clinical and semantic CT features in terms of diagnostic performance of PCP. The combination of the radiomic model and serum β-D-glucan levels was also evaluated for PCP diagnosis.

Eligibility criteria: Inclusion Criteria:

* aged over eighteen years;
* presence of an underlying disease known to be associated with PCP
* symptoms of lower respiratory tract infection, such as fever, cough or dyspnea
* signs of lung infection on high resolution CT at the on-set of the disease
* received BAL examination within three days after CT scans
* underwent qPCR and IF staining tests on the BAL fluid sample.

Exclusion Criteria:

* with HIV infection
* taking trimethoprim-sulfamethoxazole for prophylaxis
* undiagnosed by qPCR and IF staining tests

Primary outcomes:
measure: the diagnostic performance of radiomic model in the PCP diagnosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Liang-an Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04785131: Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
Official title: The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Risk
Keywords: Prune
Bone health
Oral contraceptives
Women health
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.

Detailed description: Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.

Eligibility criteria: Inclusion Criteria:

* Age 18-25

Exclusion Criteria:

* Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
* Regularly consumed dried plum or prune juice

Primary outcomes:
measure: Changes in bone mineral density from baseline to 12 months
timeFrame: At baseline, at 12 months
Secondary outcomes:
measure: Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
timeFrame: At baseline, at 6 months, at 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Shirin Hooshmand
state: California
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD, RD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07021131: Serratus Posterior Plane Block vs Erector Spine Plane Block
Official title: Continuous Serratus Posterior Plane Block Versus Continuous Erector Spine Plane Block for Video-assisted Thoracoscopic Surgery: a Prospective Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Regional Anesthesia
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 100
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: Analgesia related to the administration of local anesthetic solution into the fascia of erector spinae muscle is mediated by the effect of local anesthetic on the posterior and lateral branches of the anterior part of the spinal nerve. Comparable analgesic efficiency after the administration of both nerve blocks would reject the widespread theory of the paravertebral site of effect of the local anesthetic in ESPB.


Eligibility criteria: Inclusion Criteria:

* Patiens undergoing VATS-surgery

Exclusion Criteria:

* Age \< 20 years
* Body Mass Index \>35 kg/m2
* Technical difficulties with the nerve block administration and/or subsequent bolus application
* Abnormal course of the surgery (e.g. conversion to thoracotomy) or the postoperative phase (e.g. surgical revision of the chest)
* Patient's refusal

Primary outcomes:
measure: Cumulative opioid dose in 72 hours
timeFrame: from end of surgery to 72 hours after the end surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ústí nad Labem
country: Czechia
facility: Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
state: Ústecký kraj
Study officials:
affiliation: Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
name: Miroslava Korfova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471431: Extubation Readiness Study in Very Low Birthweight Infants
Official title: A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 81
Sex: ALL
Minimum age (years): 48
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for \>48 hours and have not yet been successfully extubated (extubated \>7 days).


Eligibility criteria: Inclusion Criteria:

* Birthweight \>500g and\<1500g.
* Postmenstrual age \<34 weeks
* Mechanically ventilated \>48 hours
* Never successfully extubated

Exclusion Criteria:

* Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
* Known or suspected airway anomalies
* Severe congenital malformations
* Need to remain intubated for other reasons (i.e. having surgery)
* Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)

Primary outcomes:
measure: time to successful extubation
timeFrame: 34 weeks postmenstrual age
Secondary outcomes:
measure: bronchopulmonary dysplasia
timeFrame: 36 weeks postmenstrual age
measure: extubation failure rate
timeFrame: 34 weeks postmenstrual age
Other outcomes:
Locations:
city: Phialdelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ann-Johanna Giaccone, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Barbara Schmidt, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397431: A Survey of Lanadelumab in Participants with Hereditary Angioedema
Official title: Specific Use-Results Survey of TAKHZYRO Subcutaneous Injection 300 Mg Syringe for Hereditary Angioedema with Long-term Administration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Angioedema (HAE)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Lanadelumab and to check if Lanadelumab improves symptoms of HAE. During the study, participants with HAE will take Lanadelumab subcutaneous injection according to their clinic's standard practice. The study doctors will check for side effects from Lanadelumab for 12 months.


Eligibility criteria: Inclusion Criteria - Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time.

Exclusion Criteria

- None

Primary outcomes:
measure: Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Angioedema Attacks
timeFrame: 12 Months
measure: Angioedema Quality of life (AE-QoL) Questionnaire
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00742131: A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors
Official title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumours
Keywords: MET inhibitor
c-Met
XL880
GSK1363089
Solid Tumors
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
* ECOG performance status of \</= 2.
* Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
* Negative pregnancy test.

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment,
* Radiotherapy within 4 weeks of the start of treatment,
* Known brain metastasis,
* Uncontrolled medical disorder such as infection or cardiovascular disease,
* HIV positive,
* Pregnant or breastfeeding women

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Eder JP, Shapiro GI, Appleman LJ, Zhu AX, Miles D, Keer H, Cancilla B, Chu F, Hitchcock-Bryan S, Sherman L, McCallum S, Heath EI, Boerner SA, LoRusso PM. A phase I study of foretinib, a multi-targeted inhibitor of c-Met and vascular endothelial growth factor receptor 2. Clin Cancer Res. 2010 Jul 1;16(13):3507-16. doi: 10.1158/1078-0432.CCR-10-0574. Epub 2010 May 14.
Clinical trial NCT05492331: A Study of Music Therapy to Support Intrauterine Insemination
Official title: A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Insemination
Keywords: Music Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure.


Eligibility criteria: Inclusion Criteria:

* IUI must be performed in the Reproductive Endocrinology and Infertility offices at Mayo Clinic in Rochester.
* IUI procedure must be on a weekday.
* IUI procedure is scheduled to be completed by a nurse in the REI Department.

Exclusion Criteria:

* Not English speaking.
* IUI procedure on a weekend day.
* IUI procedure is scheduled with an MD provider (known or expected to be difficult).
* Planned IUI procedure is cancelled prior to undergoing the procedure.
* The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
* The patient has previous participated or declined enrollment in the study during a prior IUI procedure.

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Secondary outcomes:
measure: Change in pain score
timeFrame: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
measure: Pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alessandra Ainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05077631: Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
Official title: A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Cognition Disorder
Keywords: Cognition Disorder
Alzheimer's Disease
Lead sponsor: AlzeCure Pharma
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent prior to any study-mandated procedure.´
* Willing and able to comply with study requirements.
* Healthy males and healthy women of non-childbearing potential aged ≥18 and \<65 years at screening.
* BMI ≥18.0 and ≤30.0 kg/m2 at screening.
* Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
* Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

* Planned treatment or treatment with another investigational drug within 3 months prior to randomization.
* Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
* Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
* Current smokers or users of nicotine products.
* History of alcohol abuse or excessive intake of alcohol.
* Presence or history of drug abuse.
* History of, or current use of, anabolic steroids.
* Excessive caffeine consumption.
* Plasma donation within one month of screening or blood donation prior to screening.

Primary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: 8 days
measure: Clinically significant changes in 12-lead ECGs
timeFrame: 8 days
measure: Clinically significant changes in vital signs
timeFrame: 8 days
measure: Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
timeFrame: 8 days
measure: Clinically significant changes in physical examinations
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: AlzeCure Pharma
name: Johan Sandin
role: STUDY_DIRECTOR
References:
Clinical trial NCT01429831: Aripiprazole for the Augmentation of Antidepressant Therapy
Official title: Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Taiwan Otsuka Pharm. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.


Eligibility criteria: Inclusion Criteria:

* Outpatients, either gender, 20-65 years of age
* Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:

  * Having at least one and no more than three inadequate responses of antidepressants
  * HAM-D17 score ≥ 14
* Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

* Females who are pregnant/lactating or planning to be pregnant
* Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
* History of organic mental disorder within 1 year prior to the screening visit
* Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
* Electroconvulsive therapy (ECT) for current episode
* Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
* History of substance / alcohol abuse within 1 year prior to the screening visit
* Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator

Primary outcomes:
measure: 17-Item Hamilton Depression Rating Scale (HAM-D17) score
timeFrame: Week 1, 2, 4 and 6
Secondary outcomes:
measure: Clinical Global Impression of Severity (CGI-S) score
timeFrame: Week 1, 2, 4 and 6
measure: Sheehan Disability Scale (SDS) total score
timeFrame: Week 1, 2, 4 and 6
measure: World Health Organization Quality of Life (WHOQOL-BREF) score
timeFrame: Week 6
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Te-Jen Lai, MD
role: PRINCIPAL_INVESTIGATOR
References: