louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05089747: CIRculating CANcer MAster-Protocol
Official title: MAster Protocol Studying the Impact of Blood Biopsy on Screening, Diagnosis, Diagnostic and Follow-up of Solid Cancer in Adult
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult With Solid Cancer
Keywords: liquid biopsy
solid cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 6000
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: Adult with solid cancer

Brief summary: This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease


Eligibility criteria: Inclusion Criteria:

* Adult (\>18y)
* Owing a social security insurance
* Any solid cancer diagnosed by histopathology or cytology
* Patient with blood sampling required as per standard of care
* Informed consent signed

Exclusion Criteria:

* Refusal to participate
* No blood sampling required as per standard of care
* Hemoglobin \< 7g/dl (\< 9g/dl if respiratory or cardiovascular disease history)
* Heterologous blood transfusion in the last 48 hours
* Weight under 20 kg

Primary outcomes:
measure: Liquid biopsy analyses
timeFrame: Day 0
measure: Standard technics of disease assessment
timeFrame: Week 16
measure: Correlation between outcome 1 and outcome 2
timeFrame: year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Pneumologie Hôpital Louis Pradel / Groupement Hospitalier Est
city: Lyon
country: France
facility: Service de Pneumologie Hôpital Croix-Rousse / Groupement Hospitalier Nord
city: Pierre-Bénite
country: France
facility: Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique Hôpital Lyon-Sud / Groupement Hospitalier Sud
city: Pierre-Bénite
country: France
facility: Oncologie médicale Hôpital Lyon-Sud / Groupement Hospitalier Sud
city: Pierre-Bénite
country: France
facility: Service de dermatologie Hôpital Lyon-Sud / Groupement Hospitalier Sud
Study officials:
References:
Clinical trial NCT05094947: Intermittent Catheterization Versus Trial Without Catheter
Official title: Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
acute urinary retention
intermittent catheterization
urethral catheter
trial without catheter
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 200
Sex: MALE
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, comparative, multicenter, randomized controlled trial. The aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling Foley catheter.


Eligibility criteria: Inclusion Criteria:

Men with acute urinary retention due to prostatic hyperplasia

Exclusion Criteria:

* Patient's with serious conditions and incapacity
* Previous urethral or prostate surgery.
* Urethral stricture.
* Urethrorrhagia.
* Injuries of urethra and perineum.
* Attempts of bladder catheterization within 15 days before the acute urinary retention episode.
* Urinary tract infection.
* Neurogenic bladder.
* Chronic urinary retention with a bladder volume of more than 1 liter.
* Obstructive uropathy due to the acute urinary retention.

Primary outcomes:
measure: Assessment of the quality of life
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of the restoration of self-urination.
timeFrame: 2 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow state university of medicine and dentistry named after A.I. Evdokimov
Study officials:
affiliation: Moscow state university of medicine and dentistry named after A.I. Evdokimov
name: Vigen Malkhasyan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959647: A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Official title: An Open-label, Multicenter Extension Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-sponsored Phase I or Phase II Cancer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Basal Cell Carcinoma
Metastatic Colorectal Cancer
Keywords: Hedgehog pathway inhibitor
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.


Eligibility criteria: This study only enrolled participants who took part in previous studies of vismodegib conducted by Genentech.

Inclusion Criteria:

* Completed vismodegib treatment within 2-4 weeks in a Genentech-sponsored parent study or continued to receive vismodegib at the time the Genentech-sponsored parent study closed.
* Expectation by the investigator that the participant may continue to benefit from additional vismodegib treatment.

Exclusion Criteria:

* Intervening anti-tumor therapy not specified in the parent study (ie, non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least 1 Adverse Event
timeFrame: Baseline until 30 days following the last administration of study treatment
measure: Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
timeFrame: Baseline until 30 days following the last administration of study treatment
Secondary outcomes:
measure: Incidence and Severity of All Adverse Events and Serious Adverse Events
timeFrame: 30 days following the last administration of study treatment
measure: Incidence of Adverse Events Leading to GDC-0449 Discontinuation
timeFrame: 30 days following the last administration of study treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Oakland
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Stanford
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Cincinnati
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Josina Reddy, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02717247: Transcranial Random Noise Stimulation in Food Addiction Treatment
Official title: Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)
Keywords: tRNS
Food addiction,
Obesity
Craving
functional magnetic resonance imaging (fMRI)
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.

Detailed description: Transcranial random noise stimulation is a noninvasive brain stimulation technic. The modulation of the electrical activity of the right and left dorsolateral prefrontal cortex (DLPFC) by tRNS is able to act on the phenomenon of craving in other addictions. This allows us to make the assumption that tRNS stimulation could constitute a treatment for food addiction especially in obesity.

Eligibility criteria: Inclusion Criteria:

* Female or male between 18 and 65 years old
* Patients suffering from obesity, with a BMI ≥ 30.
* Food dependence score at the Yale Food addiction Scale ≥ 3

Exclusion Criteria:

* Presence of a an other psychiatric diagnosis of Axis I (DSM IV);
* Presence of addictive comorbidity other than food addiction
* Psychotropic treatment;
* Pregnancy or lactation;
* Contraindication to fMRI .

Primary outcomes:
measure: Effects on craving frequencies
timeFrame: Change from baseline after 3 months
Secondary outcomes:
measure: change in body weight
timeFrame: Change from baseline after 3 months
measure: change in waist circumference
timeFrame: Change from baseline after 3 months
measure: change in body mass index
timeFrame: Change from baseline after 3 months
measure: change in biological markers such as lipid profile, ghrelin, leptin, prolactin
timeFrame: Change from baseline after 3 months
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Centre Hospitalier Le Vinatier
Study officials:
affiliation: CH LE VINATIER
name: D'AMATO THIERRY, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017847: Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons
Official title: Assessment of Intensity Cut Off Points for Physical Activity Measured by Activity Monitors in Elderly Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: oxygen consumption
activity monitors
METs
intensity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Maximum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons in the age of 70-76 living in Trondheim, Norway

Brief summary: Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.

Detailed description: Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.

Eligibility criteria: Inclusion Criteria:

* ability to walk at least 1km,
* born in 1938,1939,1940,1941 or 1942
* Sufficiently good health to be able to take part in the study, as determined by the researchers

Exclusion Criteria:

* Illness or disability that precludes exercise or hinders completion of the study
* Uncontrolled hypertension
* Symptomatic valve disease
* hyper tropic cardio-myopathy
* unstable angina
* Active cancer
* Test results indicating that study participation is unsafe
* Inclusion in other studies conflicting with participation in this one

Primary outcomes:
measure: Intensity of physical activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU, Faculty of Medicine Department, of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Nina Zisko, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zisko N, Carlsen T, Salvesen O, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. New relative intensity ambulatory accelerometer thresholds for elderly men and women: the Generation 100 study. BMC Geriatr. 2015 Aug 4;15:97. doi: 10.1186/s12877-015-0093-1.
Clinical trial NCT02476747: Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection
Official title: Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Keywords: Colonic polyp
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6\~10mm).

One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.

Detailed description: With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".

Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.

The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.

Eligibility criteria: Inclusion Criteria:

* All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)

Exclusion Criteria:

* (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.

Primary outcomes:
measure: complete resection rate (CRR)
timeFrame: Up to 2 months
Secondary outcomes:
measure: incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
timeFrame: Up to 2 months
measure: necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
timeFrame: Up to 2 months
measure: Polyp retrieval rate
timeFrame: Up to 2 months
measure: hospitalization period
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
name: Jeong-Sik Byeon, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01435447: Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies
Official title: Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoid Malignancies
Keywords: efficacy
safety
conditioning
fludarabine
busulfan
cyclophosphamide
adult
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.

Detailed description: Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.

Eligibility criteria: Inclusion Criteria:

* adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
* age 16-60 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)

Exclusion Criteria:

* age less than 16 years or over 60 years
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease
* other contraindication of all-HSCT

Primary outcomes:
measure: acute graft versus host disease (GVHD)
timeFrame: day 100
measure: chronic GVHD
timeFrame: 3 years
Secondary outcomes:
measure: non-relapse mortality (NRM)
timeFrame: 3 years
measure: cumulated incidence of relapse (CIR)
timeFrame: 3 years
measure: event-free survival (EFS)
timeFrame: 3 years
measure: overall survival (OS)
timeFrame: 3 years
measure: GVHD-free, relapse-free survival (GRFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood and Marrow Transplantation Center, Rui Jin Hospital
state: Shanghai
Study officials:
affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
name: Jiong Hu, m.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817947: Airway Clearance Using High Frequency Chest Wall Oscillation
Official title: An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Keywords: Airway clearance
Cystic fibrosis
High frequency chest wall oscillation
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.

Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.


Eligibility criteria: Inclusion Criteria:

* diagnosis of cystic fibrosis
* 16 years of age or over
* forced expiratory volume in one second greater than or equal to 25 percent of predicted
* hospitalised patients in a stable clinical state

Exclusion Criteria:

* current severe haemoptysis
* rib fractures
* pregnancy
* inability to give consent

Primary outcomes:
measure: Weight of sputum expectorated
timeFrame: Twenty-four hours
Secondary outcomes:
measure: Forced expiratory volume in one second
timeFrame: One hour (before and 30 minutes after treatment)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Jennifer A Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References: