louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05797493: Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
Official title: Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Cell Lung Cancer
Keywords: sclc
immunotherapy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-04
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: ES SCLC patients treated with first line chemo-immunotherapy (EP-IO

Brief summary: The scope of the PICASSO project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements.

The PICASSO project is aimed to validate in real world population the predictive role of SCLC transcriptomic classification (particularly, I-SCLC subtype) and to explore correlations with dynamic changes in peripheral blood immunity. Additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.


Eligibility criteria: Inclusion Criteria:

1. histologically- or cytologically-documented extensive-stage SCLC
2. to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors
3. No evidence of brain metastases at diagnosis
4. ECOG PS 0-2
5. adult patients (aged ≥ 18 years) at diagnosis;
6. signing of informed consent approved by the local Ethic Committee

Exclusion Criteria:

* none

Primary outcomes:
measure: PFS
timeFrame: Up to 60 months
measure: OS
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02279693: Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Raypilot dosimetry
CBCT (cone beam computed tomography)
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.

Detailed description: 10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.

Eligibility criteria: Inclusion Criteria:

* male \> 18 years
* carcinoma of the prostate histologically confirmed
* OMS 0-1
* localized stage
* favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification
* patients must have signed a written informed consent form
* patients must be affiliated to a Social Health Insurance.

Exclusion Criteria:

* metastasis
* indication for pelvic radiation
* anticoagulant therapy
* lateral or bilateral hip replacement
* patient receiving an adult protective services
* Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Primary outcomes:
measure: dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
Study officials:
affiliation: Centre Georges François Leclerc
name: Gilles CREHANGE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235493: Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09
Official title: A Single-Center, Non-interventional Substudy of ALX-HPP-502 to Assess Functional Natural History Data of Patients With Juvenile Historical Controls in ENB-006-09
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypophosphatasia
Bone Disease
Keywords: HPP
Soft Bones
low Alkaline Phosphatase
genetic metabolic disorder
alkaline phosphatase
tissue non-specific alkaline phosphatase
rickets
osteomalacia
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient has juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.

Brief summary: The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.

Detailed description: Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria: Inclusion Criteria:

* Documented informed consent/assent prior to video collection and data abstraction.
* Documented informed consent/assent in Study ALX-HPP-502.
* Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09.
* Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall
timeFrame: The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.
Secondary outcomes:
measure: Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall
timeFrame: The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.
Other outcomes:
Locations:
city: Saint Louis
country: United States
state: Missouri
Study officials:
References:
Clinical trial NCT03831893: Metabolic Effects of Nopal in Healthy Humans
Official title: Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the purpose of this study is to evaluate effects on metabolic test markers of Nopal (Opuntia) in healthy humans.

Detailed description: The study include three visits at the research unit. At two of the visits the test subjects consume nopal in different doses. At one visit the subjects will consume a reference product. The intervention products are consumed at breakfast (at 8.00) and metabolic effects are investigated 3 hours postprandially. Consumption of the intervention products is separated by a one week washout period.

Eligibility criteria: Inclusion Criteria:

Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion Criteria:

Fasting blood glucose \>6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..

Primary outcomes:
measure: Blood glucose tolerance
timeFrame: 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Secondary outcomes:
measure: subjective appetite sensations
timeFrame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
measure: Mood
timeFrame: 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food Technology, engineering and Nutrition, LTH, Lund University
Study officials:
References:
Clinical trial NCT06265493: Postoperative Infectious Complications Calculator for Elderly Patients
Official title: Postoperative Infectious Complications Calculator for Elderly Patients--A Derivation and External Validation of Prediction Models Based on Two Centers Large Sample
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Infection
Geriatrics
Prediction
Keywords: postoperative infectious complications
elderly patients
retrospective study
prediction model
calculator
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 37230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 37230 participants were included in the derivation and internal validation cohorts (29785 in the derivation cohort and 7445 in the internal validation cohort).

Brief summary: The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections.

Detailed description: Background:

Postoperative infectious complications (PICs) are related to increased morbidity, mortality, and costs, especially in elderly patients. However, published prediction models of PICs are rarely based on elderly patients.

Objective:

The study wanted to identify practical and valuable variables that could be used to predict postoperative infections and establish a convenient scoring system for clinicians to assess the risk of such conditions in elderly patients.

Methods： Data from 2 population-based cohorts of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive and validate multivariable logistic regression models. The risk prediction models were derived from 37230 patients hospitalized in the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The risk prediction models were externally validated with data from a cohort of 10252 patients hospitalized in Henan Provincial People's Hospital (November 2014 to May 2022).

Eligibility criteria: Inclusion Criteria:

1. age ≥ 65 years and
2. patients undergoing surgery with anesthesia.

Exclusion Criteria:

1. patients undergoing neurosurgery or cardiac surgery,
2. preoperative infectious diseases, and
3. patients with ≥50% of data missing.

Primary outcomes:
measure: Postoperative Infectious Complications Calculator for Elderly Patients
timeFrame: January 2012 - August 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
name: Weidong Mi, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00350493: Three Year Follow up of a Randomised Controlled Trial (RCT) of an Intervention for Tobacco Dependence Among Those With a Psychotic Illness
Official title: Three Year Follow up of a Randomised Controlled Trial of an Intervention for Tobacco Dependence Among Those With a Psychotic Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorder
Behavior, Addictive
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
First posted: 2006-07-10
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a three year follow up of a previous study where researchers at UNSW and UNewc asked smokers with serious mental health problems to participate in a 12-month study, to assess whether intervention could assist people experiencing mental illness reduce their tobacco smoking.

Detailed description: Between 2001 and 2003, the School of Public Health and Community Medicine at the University of New South Wales carried out a large study with the Centre for Mental Health Studies at the University of Newcastle. The project asked people with serious mental health problems, who also smoked cigarettes, to participate in a 12-month study, which involved completing several questionnaires/other assessments over that time with a member of the research team. Around half of the participants in this study also received treatment for their smoking from the research team. This treatment involved weekly therapy with one member of the research team, and covered the relationship between smoking and mental illness, teaching people to cope with desires to smoke, how to recognise and avoid high risk situations for smoking, and how to plan alternative ways of coping with those situations where smoking usually occurred. In addition, nicotine patches were also available to assist people who made the decision to reduce their smoking. This study hoped to learn whether this new treatment could assist people experiencing mental illness reduce their tobacco smoking.

After three years, previous participants were invited to participate in another follow-up assessment to check-in with their current situation, their mental health and levels of smoking.

Eligibility criteria: Inclusion Criteria:

* Previous participants from the original study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Centre for Mental Health Studies, University of Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: School of Public Health and Community Medicine, University of New South Wales
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Robyn Richmond, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Amanda Baker, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01078493: Wrinkle Injection With Autologous Platelet Rich Plasma Study
Official title: Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Wrinkles
Keywords: Platelet rich plasma
PRP
wrinkles
MyCells®
CREATE
Life Source Medical Centre
Dr Tan Kok leong
Lead sponsor: Novena Medical Center
Sponsor class: NETWORK
First posted: 2010-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.

Detailed description: 10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.

Eligibility criteria: Inclusion Criteria:

* Adults more than 21 years of age
* Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)

Exclusion Criteria:

* Pregnant women.
* Psychiatric patients.
* Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
* Anticoagulants(eg.aspirin, warfarin)
* Had other wrinkle therapy for less than a month.(laser, peels, injections)
* Had facelift surgery for less than a year.
* Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.
* Involved in personal litigation against an aesthetic service provider

Primary outcomes:
measure: Total Wrinkle Length
timeFrame: 3 months
Secondary outcomes:
measure: Side effect / Adverse Event
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Life Source Medical Centre @ Novena Medical Center
Study officials:
affiliation: Life Source Medical Centre @ Novena Medical Center
name: Kok Leong Tan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03049293: Measurement of Midazolam Levels in Follicular Fluid
Official title: Measurement of Midazolam Levels in Follicular Fluid and Correlation of Midazolam Levels in Follicular Fluid and Oocyte Quality, Fertilization Rate, Embryo Development Pattern and Euploid Status
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Midazolam Overdose
Keywords: COPD,IVF
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.

The reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed.

Detailed description: The correlation of Midazolam levels in follicular fluid and euploid status of the embryos is worth exploring as no data exists that suggests any influence on the quality of the embryos from using this substance for IVF since its earliest days. Measuring time lapsed from injection to first oocyte retrieval as well as time lapsed in between first and last oocyte retrieved will grand insight into the rise of levels of Midazolam inside the follicular fluid, correlated with the chromosomal status and the morphokinetic development of the euploid embryos.

Eligibility criteria: Inclusion Criteria:

* Infertility (prim. / sec.)
* Age \>18 - ≤ 38 years.
* BMI 19-30
* Stimulation in GnRH-antagonist protocol, using rFSH
* Expected normal ovarian response (6)
* At least 4 follicles with the size ≥ than 17 mm on the day of OPU
* Patients undergoing PGS
* Able to understand the aim of the study and to provide consent

Exclusion Criteria:

* History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
* Severe male factor

Primary outcomes:
measure: Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: IVI Middle East Clinic
name: Human Mo Fatemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291993: Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Vasoactive hormones
Blood pressure
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-02-15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in these patients.

The aim of this study is to measure the secretion of vasoactive hormones at night and to analyse the relationship between vasoactive hormones, oxygen saturation and the blood pressure at night.


Eligibility criteria: Inclusion Criteria:

Male and female Age 20-65 Obstructive sleep apnea

Exclusion Criteria:

Drug or alcohol abuse Pregnancy or breast feeding Cancer Clinical signs or history of disease in the heart, lungs, kidney or endocrine organs Abnormal laboratory tests Albuminuria or glucosuria Aterial hypertension for healthy subjects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
state: Ringkoebing County
city: Holstebro
country: Denmark
facility: Department of Medical Research
city: Holstebro
country: Denmark
facility: Holstebro Hospital, Department of Medical Research
Study officials:
affiliation: Holstebro Hospital, Department of Medical Research
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Holstebro Hospital, Department of Medical Research
name: Pia H Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: