louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06134245: HOme USability Evaluation
Official title: HOme USability Evaluation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 100
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: Adults with a diagnosis of solid tumour cancer, who are currently undergoing systemic anti-cancer therapy

Brief summary: To validate the usability and safety of the Liberty Analyser.


Eligibility criteria: Inclusion Criteria:

* Undergoing systemic anti-cancer therapy (SACT)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 at enrolment
* Adequate English language skills (not requiring a translator) to participate in participant training and use the Entia Liberty analyser
* Patients capable of providing written informed consent

Exclusion Criteria:

* History or current diagnosis of haematological malignancy
* Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Entia Liberty analyser or participation in training
* Inadequate use and understanding of the English language, requiring a translator

Primary outcomes:
measure: The Entia Liberty Analyser is easy to use
timeFrame: Through study completion, 1 day
measure: The Entia Liberty Analyser is safe to use
timeFrame: Through study completion, 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05497947: Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy
Official title: Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharyngeal Cancer
Swallowing Disorder
Larynx Cancer
Keywords: SOAL
patient reported outcomes
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by Total PharyngoLaryngectomy in CH Valence

Brief summary: A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Detailed description: the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.

The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Eligibility criteria: Inclusion Criteria:

* Total PharyngoLaryngectomy
* Age ≥ 18 years old
* Read, write and understand the French language

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Refusal to participate in research

Primary outcomes:
measure: SOAL- VF
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Ch Valence
state: Drome
Study officials:
affiliation: CH VALENCE
name: Guillaume BUIRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04529447: Response of Korean Medicine Hospital to COVID-19
Official title: Hospital Operational Response Strategy and Experience During the COVID-19 Pandemic in a Spine-specialty Korean Medicine Training Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 485
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients hospitalized and outpatients visiting Jaseng Hospital of Korean medicine during March 23-25, 2020

Brief summary: The objectives of this study are to report the response strategy to prevent COVID-19 spread implemented at a Korean medicine hospital, and the satisfaction survey results regarding its preventive measures.

Detailed description: The objectives of this study are (1) to report the response strategy to prevent COVID-19 spread implemented at a Korean medicine hospital situated in Seoul, Korea, (2) to describe patient visit trends compared to the number of confirmed COVID-19 cases during the COVID-19 peak in February - April 2020, and (3) to provide results of a satisfaction survey regarding its preventive measures.

Eligibility criteria: Inclusion Criteria:

* Inpatients hospitalized at Jaseng Hospital of Korean medicine during March 23-25, 2020
* Outpatients visiting Jaseng Hospital of Korean medicine during March 23-25, 2020

Exclusion Criteria:

* Visitors visiting Jaseng Hospital of Korean medicine during March 23-25, 2020 for purposes other than treatment

Primary outcomes:
measure: Satisfactory service regarding hospital response to COVID-19
timeFrame: Baseline (time of current visit)
Secondary outcomes:
measure: Feelings of apprehension regarding hospital visits
timeFrame: Baseline (time of current visit)
measure: Medical staff wearing of facial masks and hand hygiene
timeFrame: Baseline (time of current visit)
measure: Cleanliness and sterilization of hospital facilities
timeFrame: Baseline (time of current visit)
measure: Convenience and accessibility of hand sanitizers
timeFrame: Baseline (time of current visit)
measure: Helpfulness and readability of posters and stand-up banners
timeFrame: Baseline (time of current visit)
measure: Satisfaction with hospital safety measures for COVID-19
timeFrame: Baseline (time of current visit)
measure: Recommendation of hospital to friends and family
timeFrame: Baseline (time of current visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Jinho Lee, KMD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04747847: Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Official title: Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Kawasaki Disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.


Eligibility criteria: Inclusion Criteria:

* Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

Exclusion Criteria:

* Taking a CYP3A4 metabolized drug (such as cyclosporine)

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Professor
name: Adriana Tremoulet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00167947: Study Evaluating Sirolimus in Kidney Transplant Recipients.
Official title: A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure
Graft vs Host Disease
Keywords: Kidney
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 150
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: Renal function at 12 months assessed by calculated creatinine clearance.


Eligibility criteria: Inclusion Criteria:

* Age is older than 18 years.
* End-stage renal disease, with subjects scheduled for kidney transplant.
* Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusion applies.

Exclusion Criteria:

* Evidence of active systemic or localized major infection.
* Use of any investigational drug or treatment up to 4 weeks prior to study entry.
* Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
* Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
* Immunosuppression therapies other than those allowed in the protocol.
* Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.

Other exclusion applies.

Primary outcomes:
measure: To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Palermo
country: Italy
state: Sicily
city: Bari
country: Italy
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Firenze
country: Italy
city: L'Aquila
country: Italy
city: Milano
country: Italy
city: Pisa
country: Italy
city: Sassari
country: Italy
city: Siena
country: Italy
city: Udine
country: Italy
city: Varese
country: Italy
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Italy, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920347: The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial
Official title: Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic Encephalopathy
Keywords: hypoxic encephalopathy
cardiac arrest
outcome
pupillary reflex
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors after cardiac arrest

Brief summary: The trial will evaluate the use of the "Neurological Pupil index" NPi, measured with the digital pupillometer (NeurOptics) compared to clinical examination for better reliability. The investigators hypothesize that digital evaluation will offer a higher sensitivity/ specificity compared to clinical examination.

Detailed description: Absent pupillary reaction after cardiac arrest might indicate a severe hypoxic encephalopathy. Because the examination of the pupillary reaction is easy it is part of the clinical routine but due to the different medication and the dynamic process of reperfusion injury to the brain a clinical evaluation might be not precise enough. The NPi has been shown to be superior to clinical evaluation in different settings but without regard towards cardiac arrest survivors. The Pupillometer is a hand-held, cordless, and simple to use device which removes subjectivity in the measurement of pupil size and the pupillary light reflex.

Eligibility criteria: Inclusion Criteria:

* all survivors after cardiac arrest

Exclusion Criteria:

* underlying disease limiting the pupillary reflex

Primary outcomes:
measure: Neurological Pupil index (NPi) on a scale from 0-5
timeFrame: up to 7 days
Secondary outcomes:
measure: Cerebral performance category (CPC)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian Storm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00056147: Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
Official title: Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2003-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

Detailed description: The purpose of this study is to:

* assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
* explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
* identify dose(s) that will be studied in subsequent trials.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of CF
* FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
* oxyhemoglobin saturation greater than or equal to 90%
* clinically stable

Exclusion Criteria:

* abnormal renal or liver function
* clinically significant findings atypical for moderate cystic fibrosis

Primary outcomes:
measure: lung function
measure: respiratory symptoms
measure: sputum weight
measure: pulmonary exacerbations
measure: measures of lung characteristics
Secondary outcomes:
measure: safety measures
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
citation: Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):362-9. doi: 10.1164/rccm.200608-1238OC. Epub 2007 Apr 19.
Clinical trial NCT06565247: Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Official title: Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
name: Region Skane
name: Lund University
First posted: 2024-08-21
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

Detailed description: Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.

High-risk prostate cancer patients referred for radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.
3. ≥4 weeks since last biopsy of the prostate
4. One or more of the following criteria

   1. cT3, or high suspicion of extra prostatic growth on mpMRI
   2. Gleason score ≥8
   3. PSA 20-49 ng/ml
5. \>18 years
6. Given a written consent to participate in the trial

Exclusion Criteria:

1. Non-MR-safe implants or another contraindication to MRI or PET
2. Claustrophobia
3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
4. WHO PS \>1
5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
6. TUR-P within 6 months
7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
8. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
9. Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
10. Tinnitus or severe hearing loss

Primary outcomes:
measure: Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions
timeFrame: Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Region Skåne
city: Umeå
country: Sweden
facility: Region Västerbotten
Study officials:
affiliation: Region Västerbotten
name: Camilla Thellenberg Karlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826747: Intrauterine Insemination and Luteal Fase Support
Official title: Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: intrauterine insemination
luteal phase
gonadotrophins
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 393
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.


Eligibility criteria: Inclusion Criteria:

Patients with an indication for IUI:

* unexplained infertility
* mild male factor infertility
* minimal-mild endometriosis

Women:

* first IUI cycle ever
* normal ovulatory cycles (26-32d)
* age\<43,BMI≤30
* presence of at least one patent tube on hysterosalpingography and/or laparoscopy
* normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)

Men: Total motile count ≥ 5 Million/ml after capacitation

Exclusion Criteria:

* Patients with contra-indication for pregnancy , infertility or progesterone use.

Primary outcomes:
measure: clinical pregnancy rate per IUI cycle
timeFrame: by ultrasound at ± 5 to 6 weeks after IUI
Secondary outcomes:
measure: live birth rate per IUI cycle
timeFrame: 40 weeks after IUI
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
citation: Peeraer K, D'Hooghe T, Laurent P, Pelckmans S, Delvigne A, Laenen A, Welkenhuysen M, Wyns C, De Neubourg D. Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study. Fertil Steril. 2016 Nov;106(6):1490-1495. doi: 10.1016/j.fertnstert.2016.07.1096. Epub 2016 Aug 23.