louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06183151: Capillary-Venous Paired Collection
Official title: CApillary-VEnous Paired Collection (CAVE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients undergoing treatment and attending clinic for Complete Blood Count (CBC) test

Brief summary: This study is recruiting participants to donate 2 capillary blood samples to be tested on the investigational system. At the same time, remnant routine blood samples used for Complete Blood Count (CBC) testing from the same participants will be tested on the investigation system. The participants' routine CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and remnant blood samples on the investigational system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old at the time of study entry
* Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy
* Scheduled to be undergoing routine CBC blood tests as part of standard of care
* Can provide written informed consent
* In the Investigator's opinion, is able and willing to comply with all study requirements

Exclusion Criteria:

* History or current diagnosis of hematological malignancy (including bone and lymph)

Primary outcomes:
measure: To validate the measurement performance of the investigational system (bias and %bias)
timeFrame: through study completion, estimated 6 months
measure: To validate the measurement performance of the investigational system (regression)
timeFrame: through study completion, estimated 6 months
measure: To validate the measurement performance of the investigational system (CV and SD)
timeFrame: through study completion, estimated 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03028051: Chronic Pain, Life Style Factors and Quality of Life
Official title: Chronic Pain, Life Style Factors and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for multidisciplinary pain treatment.

Brief summary: Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that aims to analyze life style factors, socioeconomic and psychometric properties, metabolic problems, drug use, quality of life and biochemical variables in chronic non-cancer pain patients. The life style factors will be compared to those of normal population. At baseline, the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and blood pressure are measured, pain-related factors are recorded and blood samples taken. Changes in the quality of life of the study patients will be evaluated by questionnaires during follow-up at 2 years and 5 years.

Detailed description: Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain information on the life style factors of adult chronic pain patients referred to university hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use of health services, physical activity, smoking, use of alcohol or other substances, sleep, quality of life, nutrition and psychological factors at their first visit to the pain clinic. Height, weight, waist circumference, blood pressure and pulse are measured by the study nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL), triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician records the pain diagnosis, medication and other methods of pain management chosen. The patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.

Eligibility criteria: Inclusion Criteria:

* age 18 to 75 years
* chronic non-cancer pain
* Finnish-speaking
* referred to a multidisciplinary pain management center

Exclusion Criteria:

* inability to fill in questionnaires in Finnish
* cancer pain

Primary outcomes:
measure: Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Eija Kalso, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04243551: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
Official title: Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-01-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two-period crossover design will be used where the two possible treatment sequences will be assigned at random.
Primary purpose: TREATMENT

Brief summary: This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.

Detailed description: This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed CD diagnosis
* Seropositive
* Gluten free diet (12 months minimum)
* Experienced at least one self reported moderate or greater severity symptom during the last 28 day period
* Willing to take study treatment daily
* Must sign informed consent

Exclusion Criteria:

* Wheat allergy
* History of peptic ulcer disease, esophagitis, IBS, IBD
* Active colitis, dermatitis herpetiformis
* Diagnosed with Type 1 Diabetes
* Patients with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
* Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
* Known refractory celiac disease (RCD1 or RCD2)
* Inability to give informed consent

Primary outcomes:
measure: Symptom Severity Reduction
timeFrame: 6 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Health Related Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03554551: Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons Disease
Official title: Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parasympathetic
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria below.

Brief summary: Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls. Furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose parasympathetic denervation in PD.


Eligibility criteria: Inclusion Criteria:

* Parkinsons disease, disease duration \> 4 years, Hoehn \& Yahr stage 2-3

Exclusion Criteria:

* Significant neurological diseases (e.g. stroke, tumor)
* Significant psychiatric disease
* Previous major surgery on thoracic and/or abdominal organs
* Significant medical disease (e.g. heart- or liver failure)
* Inflammatory bowel disease
* Gluten intolerance
* Diabetes
* Magnetic Resonance (MR) contraindications (metal in body, claustrophobia)
* Allergy to CT-contrast fluid
* Pacemaker
* Any current or previous cancer involving internal organs
* Peripheral neuropathy (except Parkinsons disease related)

Primary outcomes:
measure: Density of vesicular acetylcholine transporter
timeFrame: Day 1
Secondary outcomes:
measure: Correlation to measurements of gastrointestinal denervation
timeFrame: Day 1
measure: Correlation to measurements of dysautonomia
timeFrame: Day 1
measure: Correlation to measurements of neuropsychological tests
timeFrame: Day 1
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midt
Study officials:
References:
citation: Horsager J, Okkels N, Van Den Berge N, Jacobsen J, Schact A, Munk OL, Vang K, Bender D, Brooks DJ, Borghammer P. In vivo vesicular acetylcholine transporter density in human peripheral organs: an [18F]FEOBV PET/CT study. EJNMMI Res. 2022 Apr 1;12(1):17. doi: 10.1186/s13550-022-00889-9.
Clinical trial NCT02613351: Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD
Official title: Leg Muscle Activity and Sensation During Upright Partitioned Exercise Compared to Walking: Propulsion of a 3-wheeled Scooter by Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Exercise Tolerance
Lung Diseases, Obstructive
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 15
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: The aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD: FEV1 \< 80 % and FEV1/FVC \< 0.7;
* Able to communicate in English
* Clinically stable

Exclusion Criteria:

* predominant co-morbidities or treatments that might influence the results of exercise testing

Primary outcomes:
measure: slope of the relationship between self-reported breathing and leg heaviness using Borg scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Westpark Health Care Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger S Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004551: Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)
Official title: Mood Management Training for Alcohol Dependent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Smoking
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-02-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. The second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Currently abstinent from alcohol and other drugs for at least 3 months.
* Meets criteria for history of major depression independent of alcohol use.
* Smoked an average of 10 or more cigarettes per day during the past month.
* Able to fully participate in all aspects of the study.
* Willing to participate in eight 2-hour treatment sessions and 12 months of followup.
* Willing to stop smoking and wear a nicotine patch for six consecutive weeks and refrain from participating in additional smoking interventions for the duration of treatment.

Exclusion Criteria:

* Current episode of major depression (within the last 3 months) or current or lifetime history of bipolar disorder, schizophrenia or other major psychiatric disorders.
* Current use of antidepressant, other psychotropic medications, smokeless tobacco, nicotine replacement or other smoking cessation therapy.
* Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (within 1 month) of myocardial infarction or stroke, history of severe skin allergies or evidence of severe chronic dermatoses.
* Currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Internal Medicine, Mayo Foundation
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christ A. Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497951: Photodynamic Therapy for Oral Precursor Lesions
Official title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukoplakia
Lichen
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 28
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: Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.


Eligibility criteria: Inclusion Criteria:

* Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
* Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
* Oral Lichen planus SIN III (diagnostics by Biopsie)
* Good mouth hygiene status (tartar, surface)
* Correct seat of the prosthesis and/or the denture
* Located erosions in the oral cavity
* Minimum age:18 years
* Women at the age capable of child-bearing with an appropriate contraception

Exclusion Criteria:

* Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
* Pregnancy
* less than 18
* Satisfying women
* No tobacco abuse
* satisfying therapy with local immunmodulators in lichen ruber
* surgical therapy of leukoplakia indicated

Primary outcomes:
measure: Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
timeFrame: each treatment average once a week, recall after 4 weeks
Secondary outcomes:
measure: pain due to treatment, assessed by visual analogue scale (VAS)
timeFrame: each treatment, average once a week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Bernhard Gottlieb University Clinic of Dentistry
Study officials:
affiliation: Medical University Vienna
name: Gabriella Dvorak, PD, DMD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01804751: Prediction of Adverse Perinatal Outcome for Preeclampsia in Sichuan Province of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Academy of Medical Sciences
name: Guang'an people's hospital of Sichuan province
name: The First People's Hospital of Neijiang
name: Suining Central Hospital
name: Sichuan Provincial Maternal and Child Health Care Hospital
name: Chengdu Women's and Children's Central Hospital
name: Luzhou Medical College
name: pengzhou shi fuyou baojianyuan
name: Nanchong Central Hospital
First posted: 2013-03-05
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese women who fulﬁlled a research deﬁnition of preeclampsia, and who were admitted to participating obstetric centres

Brief summary: The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china


Eligibility criteria: Inclusion Criteria:

* admitted with preeclampsia or had developed preeclampsia after admission

Exclusion Criteria:

* admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data

Primary outcomes:
measure: maternal mortality
timeFrame: within 48h of eligibility
Secondary outcomes:
measure: serious central nervous system morbidity
timeFrame: within 48h of eligibility
measure: serious cardiorespiratory morbidity
timeFrame: within 48h of eligibility
measure: serious hepatic morbidity.
timeFrame: within 48h of eligibility
measure: serious renal morbidity
timeFrame: within 48h of eligibility
measure: serious haematological morbidity
timeFrame: within 48h of eligibility
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06391151: Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes
Official title: Effect of Obstructive Sleep Apnea (OSA) Resulting From Chronic Tonsillitis on Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Chronic Tonsillitis
Pregnancy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 500
Sex: FEMALE
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: Pregnant women who have established prenatal care records and undergone antenatal check-ups at PKUFH

Brief summary: This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms.
* Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
* Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
* Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
* Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
* Pregnant women who refuse to participate in the study or are unable to provide informed consent.

Primary outcomes:
measure: preterm birth rate
timeFrame: 10 months
Secondary outcomes:
measure: delivery methods
timeFrame: 10 months
Other outcomes:
measure: pregnancy complications
timeFrame: 10 months
measure: neonatal birth weight
timeFrame: 10 months
measure: neonatal length
timeFrame: 10 months
measure: Apgar score of newborns
timeFrame: 10 months
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Xiaowan Du
role: STUDY_DIRECTOR
References: