louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05991674: A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
Official title: A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergic Contact Dermatitis
Keywords: Contact Sensitization
Patch Test
Machine Learning
Lead sponsor: Andreas Syggros Hospital of Venereal and Dermatological Diseases
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 80
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: Patch test findings from 80 ACD patients will be gathered at the National Reference Center for Occupational Dermatoses "Andreas Syggros" Hospital's Laboratory for Patch Testing.

Brief summary: The goal of this study is to look into the patterns of sensitization to figure out how allergic contact dermatitis (ACD), individual susceptibility, and patient characteristics are connected. The joint application of classic statistics and machine learning methods will reveal the relationship between contact dermatitis expressions and several clinical characteristics.


Eligibility criteria: Inclusion Criteria:

-

Eligible patients were adults diagnosed with dermatitis who had a positive patch test result on the chemical panel of Baseline Series of Allergens.

Exclusion Criteria:

-

Although there is no consensus for the definitive exclusion criteria from a patch testing, most studies agree that the chronic use of anti-inflammatory treatments, corticosteroids, and cyclosporine, high UV exposure and other chronic dermatoses are factors that might produce false- positive or false- negative results and thus should be avoided.

Primary outcomes:
measure: MOAHLFAP index
timeFrame: Clinical examination at baseline (0h)
measure: International Contact Dermatitis Research Group (ICDRG) scale
timeFrame: 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
measure: Antera 3D camera (Miravex, Dublin, Ireland)
timeFrame: 0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Georgia Gogkla
state: Attica
Study officials:
References:
Clinical trial NCT01748474: Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
Official title: Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Chronic Cardiorespiratory Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.


Eligibility criteria: Inclusion criteria:

* diagnosis of pulmonary arterial hypertension class I and IV (according to the latest WHO classification scheme of Dana Point 2008)
* on optimized medical therapy and in stable condition for at least 4 week
* desaturate in the 6 minute walking test by at least 4% to values \<92%

Exclusion criteria:

* unstable conditions
* pregnant women
* patients with pulmonary venous hypertension
* patients with relevant concomitant lung disease and severe daytime hypoxemia

Primary outcomes:
measure: Watt
timeFrame: 1 day
measure: exercise time
timeFrame: 1 day
Secondary outcomes:
measure: Peak oxygen uptake
timeFrame: 1 day
measure: Respiratory exchange ratio
timeFrame: 1 day
measure: ventilatory equivalent of carbon dioxide (VE/VCO2) slope
timeFrame: 1 day
measure: end-tidal pressures of carbon dioxide (PET CO2)
timeFrame: 1 day
measure: Changes in arterial blood parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Silvia Ulrich Somaini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ulrich S, Hasler ED, Saxer S, Furian M, Muller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.
Clinical trial NCT02358174: Hemorrhoids and Metalloproteinases, Observational Study
Official title: Hemorrhoids and Metalloproteinases, Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HEMORRHOIDS
Extracellular Matrix Alteration
Keywords: Hemorrhoids
MMP
NGAL
Matrix Metalloproteinases
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids.

The study provides potentially important insights to the understanding of the natural history of Hemorrhoids and MMPs and NGAL regulation.

Detailed description: Introduction. An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids.

Methods. In a multicenter, open-label, prospective study, patients with hemorrhoids were recruited and represented the Group I (patients with symptomatic hemorrhoids - Grade I to IV sec. Goligher), a further group of healthy volunteer subjects were also recruited as the control group (Group II).

Enzyme-linked immunosorbent assay and Western blot analysis will evaluate the levels of immunoreactive MMPs and NGAL in all patients with hemorrhoids.

Eligibility criteria: Inclusion Criteria:

* Patients with hemorrhoids of both sex

Exclusion Criteria:

* Patients with cancer
* Hepatic failure
* Infectious or autoimmune diseases
* Arthritis
* Arterial aneurysms
* Hernias
* Chronic venous disease
* Nephritis, vascular ulcers, fibrosis, and other diseases associated with increased levels of MMPs were excluded from the study.
* Patients treated with corticosteroids or cytostatic drugs were also excluded.

Primary outcomes:
measure: MMPs and NGAL plasma and tissue levels measurement in patients with hemorrhoids
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Serra R, Gallelli L, Grande R, Amato B, De Caridi G, Sammarco G, Ferrari F, Butrico L, Gallo G, Rizzuto A, de Franciscis S, Sacco R. Hemorrhoids and matrix metalloproteinases: A multicenter study on the predictive role of biomarkers. Surgery. 2016 Feb;159(2):487-94. doi: 10.1016/j.surg.2015.07.003. Epub 2015 Aug 8.
Clinical trial NCT02549274: Effectiveness of a Self-rehabilitation Program
Official title: Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicalgia
Keywords: Cervicalgia
self-rehabilitation
physiotherapy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 106
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: The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is most often based on analgesics combined with physical therapy. More recently authors have advocated the use of self-rehabilitation, that is to say, the use by the patient himself of physiotherapy exercises to perform at home regularly. However, if there are currently many studies on the effectiveness of self-rehabilitation for low back pain, there are few data on neck pain.

In this context we have chosen to implement a prospective, randomized study, on the effectiveness of self-rehabilitation in patients with chronic neck pain.

Detailed description: Patients included in the "self-rehabilitation" group will, in addition to conventional physiotherapy, to visit two training sessions in self-rehabilitation at the hospital. Each patient received a booklet including advices to perform different kinds of exercises at home. The patients learn the exercises with the help of the physiotherapist and have to traine daily at home.

Patients will have to answer questionnaires about their pain at follow-usual consultations of their disease at 2 months and 4 months after the start physical therapy and during a phone call after 1 year.

Eligibility criteria: Inclusion Criteria:

* Non-specific neck pain \* ≥ 15 days / month for more than 3 months
* Consultation first line in the pain center
* Subject able to complete questionnaires
* Subject able to understand and perform exercises

Exclusion Criteria:

* History of stroke
* History of carotid or vertebral arterial dissection
* "Whiplash" for less than six months
* Cervicobrachial neuralgia for less than 3 months
* Syndrome of thoracic outlet diagnosed
* Tumor and infectious syndromes
* Polyarthritis or major cervical spondylosis against known-indicating active mobilization of the cervical spine
* Unbound bone trauma
* Patients with cognitive impairment prevents proper application instructions

Primary outcomes:
measure: Cervical pain
timeFrame: 2 months
Secondary outcomes:
measure: cervical pain
timeFrame: 1 year
measure: cervical pain
timeFrame: 4 months
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Christelle CREAC'H, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174574: Two Cancers, One Gene. Why Some People in Families Develop Melanoma or Pancreas Cancer, While Still Others Never Develop Cancer.
Official title: Two Cancers, One Gene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Melanoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants and family members of participants currently enrolled under IRB #354-06 and #355-06 who have been identified as members of a family with at least one blood related relative with pancreas cancer, and there is a known mutation carrier of CDKN2A. Some of the family members may have previously enrolled in IRB protocol #354-06 or #355-06; others may not have ever participated in research.

Brief summary: Individuals who are affected with pancreas cancer and melanoma as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma will be asked to participate. The participant will be asked to complete a survey about their health and family history of cancer and to give a blood sample for specific gene testing and storage for future research studies.The overall goal of this study is to understand the factors that increase susceptibility and expression of pancreatic cancer and melanoma in high risk families.


Eligibility criteria: Inclusion Criteria:

* Individuals who are affected with pancreas cancer and melanoma as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma.

Exclusion Criteria:

* Under the age of 18, Non-English speaking or unable to provide informed consent, inmates.

Primary outcomes:
measure: Genomic and risk factor differences among family members who share identical predisposing CDKN2A gene mutations, with different phenotypes; will discover patterns of tumorigenesis, tissue specificity, gene-gene, and gene-environment interactions.
timeFrame: Each participant provides a research blood sample and completes a questionnaire.This is the duration of their the participant's direct involvement. The duration of generating genotypes and analysis of risk factors may extend up to two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gloria Petersen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04206774: BIO|STREAM.ICM France
Official title: BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Cryptogenic Stroke
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-12-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in French investigation sites, with an indication for Insertable Cardiac Monitors (ICM) in accordance with the European guidelines and followed with the BIOTRONIK Home Monitoring® system.

Brief summary: The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

Detailed description: The BIO\|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO\|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.

Eligibility criteria: Inclusion Criteria:

* Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
* Enrolled in the BIO\|STREAM.ICM registry

Exclusion Criteria:

* Life-expectancy is less than 3 months
* Already implanted with BIOMONITOR

Primary outcomes:
measure: SADE free rate
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
measure: R-wave amplitude
timeFrame: 3 month
measure: Noise burden
timeFrame: 3 month
measure: Ventricular rate
timeFrame: 3 month
Locations:
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
state: Caen
city: Gleizé
country: France
facility: CH Villefranche Sur Saone
city: Tours
country: France
facility: CHRU de Tours, Hopital Trousseau
Study officials:
affiliation: Hôpital Gabriel Montpied
name: Romain ESCHALIER, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04378374: The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake
Official title: The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Eating
Appetite
Food
Keywords: Pulses
Flour
Food Intake
Satiety
Blood Glucose
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and improved blood glucose control. However, it is not clear whether these effects still remain after the processing of pulses into flours. The investigators hypothesized that the baked food products formulated with lentil flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia and elicit a stronger suppression of subjective appetite due to its higher content of protein and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be formulated either with lentil flour or with all-purpose wheat flour of similar particle size or with their combination. The objective of the project is to test the effect of foods formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and subjective appetite.


Eligibility criteria: Inclusion Criteria:

* Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2

Exclusion Criteria:

* Breakfast skippers
* Smokers (including e-cigarettes) / cannabis consumers
* Those with BMI \< 18.5 and \> 24.5 kg/m2
* People with chronic diseases
* People with impaired blood glucose control
* People taking medication that may affect central and peripheral mechanisms of food intake regulation, blood glucose control, cognitive performance and sedative medication.
* People with intellectual disabilities (excluded due to their inability to comprehend hedonic and visual analogue scales used in the study).
* People with food allergies or gastrointestinal disorders (e.g., IBS and others).

Primary outcomes:
measure: Blood Glucose
timeFrame: 0-120 minutes
measure: Food Intake
timeFrame: 120 minutes
measure: Subjective Appetite
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Physical Comfort
timeFrame: 0-120 minutes
measure: Palatability of Food
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: Mount Saint Vincent University
name: Bohdan Luhovyy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830674: A Study of KRN23 in X-linked Hypophosphatemia
Official title: A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: X-linked Hypophosphatemia
Keywords: XLH
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2009-01-28
Enrollment: 42
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: The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Clinical diagnosis of XLH
3. TmP/GFR is less than 2.0 mg/dL
4. GFR is 60 mL/min or above

Exclusion Criteria:

1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
2. History of known immunodeficiency
3. Lactating females, female patients who are pregnant or planning to become pregnant during the study
4. Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
5. Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
6. Receipt of live (attenuated) vaccine within 3-months prior to screening
7. Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Primary outcomes:
measure: Safety and tolerability
timeFrame: Up to 7 weeks after dosing (maximally 11 weeks)
Secondary outcomes:
measure: Effect to pharmacodynamic parameter
timeFrame: Up to 7 weeks after dosing (maximally 11 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Indianapolis
country: United States
facility: General Clinical Research Center, Indiana University School of Medicine
state: Indiana
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Yale University
name: Thomas O. Carpenter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter TO, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Wooddell MM, Kawakami T, Ito T, Zhang X, Humphrey J, Insogna KL, Peacock M. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 2014 Apr;124(4):1587-97. doi: 10.1172/JCI72829. Epub 2014 Feb 24.