louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02877706: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Official title: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Thrombocytopenia
Autoimmune Hemolytic Anemia
Keywords: Registry
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 1500
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: Multicentric adult ITP and AIHA case recording in France, selected in centers of the French Referral Autoimmune Cytopenia Network. Both secondary and tertiary (referral) centers are participating (N=44).

Brief summary: CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.


Eligibility criteria: Inclusion Criteria:

* adult patients (18+ year-old)
* newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

- opposition to data collection

Primary outcomes:
measure: Incidence of Immune thrombocytopenia (ITP) and AIHA
timeFrame: Baseline
measure: Natural evolution and events
timeFrame: Baseline and follow-up
Secondary outcomes:
measure: Response
timeFrame: 15 years
measure: Complete rate
timeFrame: 15 years
measure: Treatment lines
timeFrame: 15 years
measure: Adverse drug reactions
timeFrame: 15 years
measure: Bleeding
timeFrame: 15 years
measure: Rescue treatment
timeFrame: 15 years
measure: Adherence to ITP management guidelines.
timeFrame: 15 years
measure: Events
timeFrame: 15 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de Médecine Interne
Study officials:
affiliation: University Hopsital Toulouse
name: Moulis Guillaume, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01967706: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Nicotine absorption
Candidate modified risk tobacco product
Cigarette
Nicotine replacement therapy
Nicotine gum
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 73
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).


Eligibility criteria: Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a medication (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT
timeFrame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
measure: Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT
timeFrame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: Ageo Medical Clinic, 3133 Haraichi, Ageo-shi
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Ageo Medical Clinic
name: Fumimasa Nobuoka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746406: A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urology
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).


Eligibility criteria: Inclusion Criteria:

* Children (2 to 18 years old)
* Subjects who perform CIC regularly
* Must be able to understand English instructions (written or oral)

Exclusion Criteria:

* Subjects suffering from symptomatic bladder infection

Primary outcomes:
measure: Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.
timeFrame: Through study completion, an average of 4 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04270799: Lung Nodule Imaging Biobank for Radiomics and AI Research
Official title: Lung Nodule Imaging Biobank for Radiomics and AI Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Pulmonary Nodule, Multiple
Pulmonary Nodule, Solitary
Lung Neoplasms
Keywords: Incidental lung nodules
Radiomics
Artificial Intelligence
Machine Learning
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: RM Partners West London Cancer Alliance
name: Royal Brompton & Harefield NHS Foundation Trust
name: University College London Hospitals
name: Imperial College Healthcare NHS Trust
name: Lewisham and Greenwich NHS Trust
name: King's College Hospital NHS Trust
name: Epsom and St Helier University Hospitals NHS Trust
name: Institute of Cancer Research, United Kingdom
name: Guy's and St Thomas' NHS Foundation Trust
name: UCLH Biomedical Research Centre
First posted: 2020-02-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previously identified lung nodules.

Brief summary: This study will collect retrospective CT scan images and clinical data from participants with incidental lung nodules seen in hospitals across London. The investigators will research whether machine learning can be used to predict which participants will develop lung cancer, to improve early diagnosis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Baseline CT thorax imaging reported as having pulmonary nodule(s) between 5 and 30mm in the last 10 years.
* Ground truth known (either scan data showing stability for 2 years (based on diameter) or one year (based on volumetry), complete resolution, or biopsy-proven malignancy.
* Slice thickness \< 2.5mm.

Exclusion Criteria:

* • Absence of at least one technically adequate CT thorax imaging series (defined by visual inspection of presence of imaging data of the thorax in the DICOM record).

  * Slice thickness \> 2.5mm.
  * Imaging \> 10 years old.
  * Ground truth unknown.

Primary outcomes:
measure: Development of an imaging biobank
timeFrame: 1 year
Secondary outcomes:
measure: Discovery of a CT-thorax based radiomics profile to predict cancer risk.
timeFrame: 1 year
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust
state: Greater London
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier's Hospitals NHS Trust
state: Surrey
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Brompton NHS Foundation Trust
Study officials:
affiliation: The Royal Marsden Hospital
name: Richard Lee, MBBS PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02968199: Building a Community-based Network to Promote Smoking Cessation
Official title: Development of a Community-based Network to Promote Smoking Cessation Among Female Smokers in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 457
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study describes the development of a community-based network to promote smoking cessation among female smokers in Hong Kong.

Detailed description: There is growing concern about the use of tobacco among women in Hong Kong. Nevertheless, nearly all of them reported that they had not attended smoking cessation services provided by the government and other organizations, of which only 6.7% indicated that they would like to attend, demonstrating the need for population-based smoking cessation interventions targeting female smokers in Hong Kong. In response to the increased number of female smokers and their low usage rates of smoking cessation services, the first smoking cessation hotline for female smokers in Hong Kong was established in 2006 by the University of Hong Kong. The aim of this study was to describe the development of a community-based network to promote the smoking cessation hotline among female smokers in Hong Kong.

Eligibility criteria: Inclusion Criteria:

* Female Hong Kong Chinese current smokers
* Aged 15 years or above
* Able to speak and understand Cantonese
* Willing to receive face-to-face or telephone counseling

Exclusion Criteria:

* Those who were participating in other smoking cessation programs or services

Primary outcomes:
measure: self-reported 7-day point prevalence of abstinence
timeFrame: 6 months
Secondary outcomes:
measure: self-reported reduction of ≥ 50% in cigarette consumption
timeFrame: 6 months
measure: Levels of self-efficacy at baseline
timeFrame: baseline
measure: Levels of self-efficacy at six months
timeFrame: six months
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: William, Ho Cheung LI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li WH, Chan SS, Wan ZS, Wang MP, Ho KY, Lam TH. Development of a community-based network to promote smoking cessation among female smokers in Hong Kong. BMC Public Health. 2017 Apr 11;17(1):311. doi: 10.1186/s12889-017-4213-z.
Clinical trial NCT06283199: Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.
Official title: The Importance of Ecological Momentary Assessment to Capture the Whole Patient's Symptoms Experience in Musculo-skeletal Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Pain
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with musculoskeletal chronic pain with a clinical and imaging diagnosis of an orthopaedic disease such as knee osteoarthritis, hip osteoarthritis, shoulder osteoarthritis, ankle osteoarthritis, rizoathrosis, meniscectomy treatment, rotator cuff tendinopathy, low-back pain, Achille tendinopathy, patellar tendinopathy,and tennis elbow.

Brief summary: Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.

After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients
* Patients able to give informed consent and to follow the protocol of the study (i.e. able to use a smartphone)
* Patients \>18 years
* BMI \<35 and \>18.5
* Patients with a smartphone with Android or iOS as operative systems

Exclusion Criteria:

* Patients unable to follow the protocol of the study (i.e. unable to use a smartphone, not owning a smartphone or unwilling to download or use the application)
* Patients with a diagnosis of a musculoskeletal injury but without symptoms
* Patients without a radiological examination confirming the diagnosis of musculoskeletal disease
* Patients with planned surgery in the following 60 days
* Pregnant or lactating woman
* Patients with other diseases causing pain in the involved joint (e.g. rheumatoid arthritis or other rheumatologic diseases).
* Surgical treatment in the last year and intra-articular injection in the last 6 months

Primary outcomes:
measure: Difference in pain level
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
city: Lugano
country: Switzerland
facility: EOC - Orthopaedics and Traumatology Service
Study officials:
References:
Clinical trial NCT05577299: Factors Affecting BAT Activation in PET/CT
Official title: Factors Affecting Brown Adipose Tissue (BAT) Activation in Cancer Patients Undergoing 18F-FDG-PET/CT
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Factors Affecting BAT Activation in PET/CT
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients undergoing PET/CT

Brief summary: The aim of the present study is to evaluate the factors affecting BAT activation in 18F-FDG-PET/CT in different tumours

Detailed description: Positron emission tomography (PET)/CT with fluorine-18 fluorodeoxyglucose (18F-FDG) is currently a standard diagnostic tool for identifying tumours and their metastases as well as infectious or inflammatory lesions.1-3 High physiological uptake of 18F-FDG is found in organs with high glucose metabolism, such as the brain and heart. One particular tissue with high 18F-FDG uptake that can interfere with scan interpretation is brown fat.4 Brown fat, or brown adipose tissue (BAT), is involved in non-shivering thermogenesis and creates heat through glucose metabolism. It is found mostly in the cervical, supraclavicular and thoracic paravertebral regions,5 and some is also found in the axillae, mediastinum and abdomen.6 Although it is usually simple for nuclear medicine physicians to recognize BAT uptake through its typical pattern and from the low attenuation in the CT scan, high uptake in BAT can still be mistaken for a malignant lesion or cause false-negative results by obscuring small metastases and decrease diagnostic confidence of the scan professional reading. BAT has a preferential distribution over the body and a preferential occurrence in female, younger and thinner patients. It mainly interferes with scan interpretation in tumours that occurs at younger age and is located in or metastasize to the head, neck and peri clavicular/axillary regions, such as melanoma of the upper body, breast cancer, and head and neck cancers, but it can also cause problems in lung and other cancers.7.8

Eligibility criteria: Inclusion Criteria:

* This study will include all patients presented with different types of tumors.
* patients conscious to provide informed consent

Exclusion Criteria:

* • Patients who have contraindications to PET/CT scanning such as: a blood glucose level higher than 150-200 mg/dL, uncontrolled diabetics.

  * Intolerance of PET/CT due to claustrophobia will be excluded from the study.
  * Patients under age of 18

Primary outcomes:
measure: the main factors that affect appearance of BAT in PET/CT studies and try to avoid these factors.
timeFrame: from 7/2019 to 7/2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00583999: The Role of Leptin Receptors in NASH
Official title: Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Steatohepatitis
Metabolic Syndrome
Keywords: leptin, leptin receptors, adiponectin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for bariatric surgery

Brief summary: NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD.

Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective bariatric surgery, ages 18-65.

Exclusion Criteria:

* non-obese patients, ages less than 18 and over 65. Pregnant patients.

Primary outcomes:
measure: To link SLR to grade/stage of NASH
timeFrame: 2.5 years
Secondary outcomes:
measure: To link SLR, leptin and adiponectin to features/components of the metabolic syndrome
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Natalie Torok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Medici V, Ali MR, Seo S, Aoki CA, Rossaro L, Kim K, Fuller WD, Vidovszky TJ, Smith W, Jiang JX, Maganti K, Havel PJ, Kamboj A, Ramsamooj R, Torok NJ. Increased soluble leptin receptor levels in morbidly obese patients with insulin resistance and nonalcoholic fatty liver disease. Obesity (Silver Spring). 2010 Dec;18(12):2268-73. doi: 10.1038/oby.2010.95. Epub 2010 May 6.
Clinical trial NCT01915199: Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting
Official title: Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: City of Turku
name: Social Insurance Institution, Finland
First posted: 2013-08-02
Enrollment: 144
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The implementation of lifestyle modifications, home blood pressure (BP) measurement, and optimization of antihypertensive drug therapy have been shown to improve BP control in tightly controlled research settings. The investigators objective is to determine the effect of these interventions in a primary care setting, with the family practitioners and nurses serving as the interventionists. The investigaotrs hypothesis is that a comprehensive intervention performed in a primary care setting would lead to better blood pressure control.


Eligibility criteria: Inclusion Criteria:

* Aged 35-74 years
* Untreated office blood pressure of ≥ 160/100 mmHg or on active antihypertensive treatment.

Exclusion Criteria:

* Severe psychiatric or neurologic illnesses
* Heart failure (ejection fraction \< 40% or previous hospitalization for heart failure)
* Hemodynamically significant valvular disease
* Unstable coronary heart disease
* Chronic kidney disease (proteinuria \> 1 g/l or a serum creatinine concentration \> 160 mmol/l)

Primary outcomes:
measure: Change in Office Systolic and Diastolic Blood Pressure
timeFrame: Baseline and at 12 Months.
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Population Studies Unit
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Antti Jula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Teemu Niiranen, MD
References:
citation: Niiranen TJ, Leino K, Puukka P, Kantola I, Karanko H, Jula AM. Lack of impact of a comprehensive intervention on hypertension in the primary care setting. Am J Hypertens. 2014 Mar;27(3):489-96. doi: 10.1093/ajh/hpt204. Epub 2013 Nov 1.