louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00578409: Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data
Official title: Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: castration resistant prostate cancer
progressive castrate metastatic prostate cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Aureon Biosciences, Inc.
name: NYU MEDICAL CENTER
First posted: 2007-12-21
Enrollment: 758
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage 1 - Population: Progressive Metastatic Disease Stage 2 - Population: Rising PSA

Brief summary: We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H\&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.


Eligibility criteria: Inclusion Criteria:

Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.

For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..

Exclusion Criteria:

For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4

• (MSKCC - add reference if publication available for rising PSA patients)

Primary outcomes:
measure: The analysis for the progressive castrate mets disease population consists of two analytical steps. The first step involved the development of a predictive model of pt survival using supervised multivariate analytical (SMA)techniques
timeFrame: 2 years
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: Howard I Scher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00529009: Pharmacokinetic Investigation of UDCA in Bile and Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK analysis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2007-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state.

Detailed description: see protocol

Eligibility criteria: Inclusion Criteria:

* PBC or healthy

Exclusion Criteria:

* pathology which does interfere with safety or PK of UDCA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Beuers
Study officials:
affiliation: University of Amsterdam
name: Ulrich Beuers, MD
role: STUDY_CHAIR
References:
citation: Dilger K, Hohenester S, Winkler-Budenhofer U, Bastiaansen BA, Schaap FG, Rust C, Beuers U. Effect of ursodeoxycholic acid on bile acid profiles and intestinal detoxification machinery in primary biliary cirrhosis and health. J Hepatol. 2012 Jul;57(1):133-40. doi: 10.1016/j.jhep.2012.02.014. Epub 2012 Mar 10.
Clinical trial NCT06213909: Retrospective Study of the Effects of Sub-pathologic Phenotypes of BP on Clinical Management and Prognosis
Official title: A Retrospective Study of the Effects of Different Pathologic Phenotypes of Bullous Pemphigoid on Clinical Management and Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bullous Pemphigoid
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 318
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients with BP who were first admitted to the Department of Dermatology of Xijing Hospital with a clear diagnosis, complete information on skin histopathology slides, and were of any gender and age.

Brief summary: Bullous pemphigoid (BP) is a chronic autoimmune subepidermal blistering disease primarily affecting the elderly with a significant risk of mortality and morbidity. Various inflammatory cells such as eosinophils, lymphocytes, neutrophils and their granulopoiesis play an important role in the pathogenesis of BP. Infiltration of peripheral blood eosinophils, lymphocytes, and neutrophils into the skin is considered a major feature of BP, making it a heterogeneous disease with different histologic and clinical subtypes. This clinical study was conducted to further investigate the impact of different pathologic phenotypes of BP on the treatment and prognosis of the disease. A retrospective epidemiologic investigative approach was used，and case collection included demographic information, medical history, clinical manifestations, and histopathologic features. Including gender, age, duration of disease, number of days of hospitalization, mucosal involvement, clinical diagnosis before admission, histopathological diagnosis, laboratory tests, concomitant diseases, treatment and its changes in laboratory indexes before and after treatment.


Eligibility criteria: Inclusion Criteria:

* (1) Patients with Bullous Pemphigoid who were first hospitalized in the Department of Dermatology of Xijing Hospital
* (2) Age 0-100 years old, gender is not limited.
* (3) Diagnosis is confirmed by clinical, histopathologic, immunopathologic and/or anti-BP180 antibody tests.
* (4) Complete skin histopathology information

Exclusion Criteria:

* (1) Patients with Bullous Pemphigoid who were not first diagnosed in our hospital.
* (2) Those who have received systemic glucocorticoid, immunosuppressant, biologic, or other drug therapy within the past month.

Primary outcomes:
measure: Bullous Pemphigoid Disease Area Index (BPDAI) severity score
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Department of Xijing Hospital
name: Gang Wang, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04248309: Serum Progesterone Level in HRT-FET：a RCT
Official title: The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 423
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the window of implantation, progesterone plays an important role. Sufficient serum progesterone is basic for ongoing pregnancy. Vaginal progesterone is more and more widely used in ART. As it has no hepatic first pass effect. What is the optimal serum level for pregnancy when use vaginal progesterone is not known yet? Hormone replacement therapy- FET is the optimal strategy to explore this question. There are some retrospective studies showed that the serum progesterone level on embryo transfer day (D3 or D5) or pregnancy test day (D14) lower than 10-11ng/ml is significantly associated with ongoing pregnancy rate in HRT-FET cycles. This prospective study is designed to compare the ongoing pregnancy rate between different serum progesterone levels on D3 and to explore the intervention of additional progesterone supplement since D3 is helpful in HRT-FET cycles.


Eligibility criteria: Inclusion Criteria:

1. HRT-FET cycles，including GnRHa-HRT-FET
2. Age\<41 years old
3. BMI\<30kg/m2
4. TSH and PRL normal
5. Endometrium thickness ≥8mm on D0 6） embryo transfer completed with at least 1 top-quality embryo (7-9 cell Grade 1 or D5 beyond grade 3 ) 7） Scandalized luteal phase support： transvaginal progesterone 0.2 tid with or without oral progesterone 10mg bid 8） included once for every patient

Exclusion Criteria:

1. history of Moderate and Severe uterine adhesion；
2. presence of hydrosapinx diameter \>2cm
3. Endometrosis at stage III-IV
4. Recurrent implantation failure (\>3 times of embryo transfer cycle)

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 weeks after embryo transfer
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 10 weeks after embryo transfer
Other outcomes:
Locations:
Study officials:
References:
citation: Haiyan L, Gang Y, Yu L, Lin L, Xiaoli C, Qingxue Z. Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):3. doi: 10.1186/s13063-021-05953-8.
Clinical trial NCT03307109: Quality of Life in Patients Having a Prosthetic Joint Infection
Official title: Quality of Life in Patients Having a Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Prosthetic Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 250
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: Patients having an prosthetic joint infection

Brief summary: Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high.

These bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home.

To the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection.

The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.


Eligibility criteria: Inclusion Criteria:

* Patient having prosthetic joint infection
* Patient who did not object to participate in the study
* Patients over 18 years of age

Exclusion Criteria:

* Patient with additional psychological or psychiatric support outside the service.
* Patient benefiting from a system of legal protection (safeguard of justice, guardianship, curatorship)
* Patient participating in another study on measuring quality of life
* Patients with cognitive impairment to understand the questionnaire
* Impossibility of giving the patient informed information
* Patients with no infection diseases follow up at the CROIX ROUSSE hospital
* Patients with amputation as initial surgery for infection management

Primary outcomes:
measure: Questionnaire EQ-5D-3L
timeFrame: 12 to 24 months
measure: Analog Visual Scale
timeFrame: 12 to 24 months
Secondary outcomes:
measure: Questionnaire EQ-5D-5L
timeFrame: 12 to 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de reference des infections ostéo-articulaires de Lyon
Study officials:
References:
Clinical trial NCT04530409: Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
Official title: Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Covid19
Corticosteroids
Keywords: COVID19
dexamethazone
methylpredisolone
early recovery
Lead sponsor: ClinAmygate
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 752
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: Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Detailed description: The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.

The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.

Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Eligibility criteria: Inclusion Criteria:

* any case with COVID-19 more than or equal to 18 years
* mild and moderate severity

Exclusion Criteria:

* Severe to critical COVID-19
* Any contra-indication for the interventional drug
* Mentally disabled cases

Primary outcomes:
measure: Percentage of cases that will need hospitalization
timeFrame: 10 days
measure: Percentage of cases that will need oxygen supplementation
timeFrame: 10 days
measure: 28-days mortality
timeFrame: 28 days
Secondary outcomes:
measure: Percentages of COVID-19 Severity according to CDC 2020
timeFrame: 10 days
measure: Time to return to daily activity
timeFrame: 60 days
measure: Percentage of cases with increased d-dimer
timeFrame: 10 days
measure: Percentage reduction in CRP
timeFrame: 10 days
measure: Percentage reduction in LDH
timeFrame: 10 days
measure: Percentage reduction in Ferritin
timeFrame: 10 days
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Asalam
state: Cairo
Study officials:
affiliation: Assalam Clinics
name: Emad R Issak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
Clinical trial NCT04942509: Mindful Coloring to Reduce Nurses' Stress
Official title: Coloring as a Brief Mindfulness-based Intervention for Stress Reduction Among Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress (Psychology)
Burn Out (Psychology)
Keywords: nurses
coloring
brief mindfulness-based intervention
mental well-being
mindfulness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: City University of Hong Kong
First posted: 2021-06-28
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were allocated into the experimental and wait-list control groups. The experimental group colored for at least 5 days during a 10-day period while the control group did not.
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate whether nurses who did mindful coloring for at least five working days during a 10-day period experienced stress reduction afterwards.

Detailed description: Enrolled participants who met inclusion criteria (full-time clinical nurses working for at least five days during a specified 10-day period) were randomized in 1:1 ratio to the coloring or control groups. A third party did the allocation sequence and concealment. After giving informed consent, participants completed the baseline questionnaire and the coloring group watched an instructional video on mindful coloring. The coloring group were asked to color for any length of time on at least five working days during a 10-day period (period A) while the control group were asked to do it on a subsequent 10-day (period B). The post-intervention questionnaire was completed by both groups at the end of period A. The study was completed after period B.

Eligibility criteria: Inclusion Criteria:

* Full time clinical nurses working under the Hospital Authority who would be working for at least 5 days during a specified 10-day study period.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in perceived stress
timeFrame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
Secondary outcomes:
measure: Change in mental well-being
timeFrame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
measure: Change in burnout
timeFrame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
measure: Change in trait mindfulness
timeFrame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Shuk Yan Janet Fong, MSocSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fong JSY, Hui ANN, Ho KM, Chan AKM, Lee A. Brief mindful coloring for stress reduction in nurses working in a Hong Kong hospital during COVID-19 pandemic: A randomized controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31253. doi: 10.1097/MD.0000000000031253.
Clinical trial NCT03753009: Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
Official title: Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 28
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty eyes of 28 consecutive pediatric patients (7 female and 21 male; mean age 14.3±2.5 \[SD\] years; range, 9 to 18 years) affected by keratoconus (diagnosis established according to global consensus on keratoconus and ectatic diseases) who underwent iontophoresic transepithelial corneal cross-linking by or epithelium-off corneal cross-linking are enrolled in this retrospective study

Brief summary: To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.

Detailed description: Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 \[SD\] years; range, 9 to 18 years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest point and thickness of the thinnest point mean values were evaluated. A Student t test was used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression in function of preoperative Kmax value and cone location was evaluated at 36 months.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Keratoconus age \< 18 years at the treatment; corneal cross linking performed at least 3 years before

Exclusion Criteria:

* age \> 18 years at the treatment

Primary outcomes:
measure: keratoconus stability
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bambino Gesù Children's Hospital, Rome, Italy
name: Luca Buzzonetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05025709: Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology
Official title: Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchospasm
Keywords: bronchial spasm
general anaesthesia
allergy
anaphylaxis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included were those referred to the allergy consultation (dermato-allergology department of the Nancy University Hospital), over a period from October 2017 to March 2021, for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure. There were no exclusion criteria.

Brief summary: Bronchospasm during anaesthesia is a rare but potentially life-threatening event. They are classically part of IgE-dependent anaphylaxis but can also occur as an independent clinical entity, triggered by inflammatory factors such as smoking, chronic bronchitis, asthma, overweight and mechanical factors such as tracheal intubation.

The etiological diagnosis is currently established during an allergy-anaesthesia consultation after skin testing for drugs used for induction of anaesthesia and antibiotic therapy when it is attributable.

The aim of this study was to determine the characteristics that differ between 2 groups: isolated non-allergic bronchospasm and bronchospasm as part of an immediate allergic hypersensitivity reaction.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the allergy consultation for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure.

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical reactions
timeFrame: Baseline (J0)
measure: Treatments provided
timeFrame: Baseline (J0)
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Dermato-allergology department of the Nancy University Hospital
Study officials:
References: