louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01133782: Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Tract Infection
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Strama - the Swedish strategic programme against antibiotic resistance.
name: Capio Research Foundation
First posted: 2010-05-31
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation.
* Symptom duration of less than 14 days

Exclusion Criteria:

* \>14 days of symptoms
* confirmed bacterial infection
* Hospital acquired infection (\>3days in hospital)

Primary outcomes:
measure: Antibiotic treatment prescriped at initial visit
timeFrame: Within 2 days of initial visit
Secondary outcomes:
measure: Antibiotic treatment prescribed or reported at follow-up visit
timeFrame: 10+/-2 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Infectious Diseases, Sahlgrenska University Hospital
Study officials:
References:
citation: Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson LM. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial. BMC Med. 2011 Apr 26;9:44. doi: 10.1186/1741-7015-9-44.
Clinical trial NCT04104282: the Role of plin5 in the Development of Nonalcoholic Fatty Liver Disease.
Official title: the Role of plin5 in the Development of a Sequence Polymorphism in Patatin-like Phospholipid Domain Containing Protein 3 Polymorphism-associated Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Nonalcoholic fatty liver disease
Lipid droplets
Plin5
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with was confirmed by clinical presentation, ultrasound and laboratory test. At the same time, participants who enrolled this statistical analysis without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases. (range, 18-75 years).

Brief summary: To further clarify the role of sequence polymorphism in patatin-like phospholipid domain containing protein 3 in the development of nonalcoholic fatty liver disease.

Detailed description: A sequence polymorphism in patatin-like phospholipid domain containing protein 3 is significantly associated with nonalcoholic fatty liver disease, but its mechanism underlying this association remains obscure. We introduce the human samples of liver to clarify the relationship between the expression of plin5 and the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease, analyze the lipid metabolism and lipotoxicity of hepatocytes to elucidate the mechanisms of plin5 in the development of sequence polymorphism in patatin-like phospholipid domain containing protein 3 variant-associated nonalcoholic fatty liver disease. Our study will contribute to the mechanism of nonalcoholic fatty liver disease, and its prevention and therapy.

Eligibility criteria: Inclusion criteria:

The diagnosis of simple fatty liver disease was confirmed by clinical presentation, ultrasound, and without long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.

Exclusion criteria:

With long-term drinking history, viral hepatitis, medication history, obesity (BMI≥30), type 2 diabetes and other metabolic diseases.

Primary outcomes:
measure: The severity of non-alcoholic fatty liver disease
timeFrame: 3 months
Secondary outcomes:
measure: The expression of plin5
timeFrame: 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Department of Ultrasonic Medicine, The Xijing Hospital of Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: The Xijing Hospital of Fourth Military Medical University
name: Ming Yu, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04507282: Eosinophil and Anticoagulation in COVID-19 Patients
Official title: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID 19 positive patients treated with LMWH

Brief summary: Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
* agreed to participate in the study were included

Exclusion Criteria:

* Patients with previous coagulopathy,
* continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve disease),
* glomerular filtration rate (GFR) \<30 mL/min or undergoing dialysis, or with known liver dysfunction were excluded from the study.

Primary outcomes:
measure: subprophylactic anticogulation level
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Yıldırım
country: Turkey
facility: Bursa Yüksek İhtisas Hastanesi
Study officials:
References:
citation: Ari S, Can V, Demir OF, Ari H, Agca FV, Melek M, Camci S, Dikis OS, Huysal K, Turk T. Elevated eosinophil count is related with lower anti-factor Xa activity in COVID-19 patients. J Hematop. 2020 Oct 8;13(4):249-258. doi: 10.1007/s12308-020-00419-3. eCollection 2020 Dec.
Clinical trial NCT00153582: WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
Official title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.

Detailed description: In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.

Eligibility criteria: Inclusion Criteria:

* AML or myelodysplastic syndromes (MDS)
* Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
* HLA-A2+
* WT1-expression in bone marrow

Primary outcomes:
measure: Generation of T cell response
Secondary outcomes:
measure: Clinical outcome
measure: Safety
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hematology&Oncology Charité CBF
Study officials:
affiliation: Charité
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mailander V, Scheibenbogen C, Thiel E, Letsch A, Blau IW, Keilholz U. Complete remission in a patient with recurrent acute myeloid leukemia induced by vaccination with WT1 peptide in the absence of hematological or renal toxicity. Leukemia. 2004 Jan;18(1):165-6. doi: 10.1038/sj.leu.2403186. No abstract available.
Clinical trial NCT05753982: Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
Official title: Infuence of Kinesiotaping on Pulmonary Function Improvement in Multiple Rib Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Wall Injury
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 40
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: Elastic tapes, named "kinesiotapes" have a limited, but proven influence on pain reduction, improvement in muscular strength and joint function. It can be hypothetised that by using kinesiotape techniques on damaged chest wall (due to mostly rib fracture) we can improve not only analgesia, but also improve lung function tests and speed recovery.

Detailed description: Chest wall injury changes the function of chest wall muscles and other structures, which in turn influences respiratory function and cause significant pain.

Elastic tapes, named "kinesiotapes" have a limited, but proven influence on pain reduction, improvement in muscular strength and joint function. It can be hypothetised that by using kinesiotape techniques on damaged chest wall (due to mostly rib fracture) we can improve not only analgesia, but also improve lung function tests and speed recovery.

Eligibility criteria: Inclusion Criteria:

* Unilateral chest wall injury with multiple rib fracture (\< 5 ribs)
* Signed informed consent

Exclusion Criteria:

* Minors
* Pregnant women
* Contraindications of using kinesiotapes
* Contraindications to perform spirometry (lung function tests)
* Inability to cooperate
* Chest drains
* Pneumothorax

Primary outcomes:
measure: Improved spirometry tests
timeFrame: 2 days
Secondary outcomes:
measure: Reduction in opioid consumption
timeFrame: 2 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
Clinical trial NCT03259282: Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis
Official title: Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcoidosis

Brief summary: Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in a retrospective cohort of patients at Rennes University Hospital

Detailed description: In 50% of cases, sarcoidosis is associated with polyclonal hypergammaglobulinemia. The other forms have a normal gamma globulin level.

The level of gamma globulinemia has not yet been studied as an evolutionary predictive factor. Furthermore, there are disseminated granulomatoses sharing common characteristics with sarcoidosis, associated with Common Variable Immunodeficiency deficit (DICV) type Primary Immunodeficiency syndrome (DIP), thus occurring in hypogammaglobulinemic patients.

Eligibility criteria: Inclusion Criteria:

- Patients newly diagnosed with sarcoidosis

Exclusion Criteria:

* Comorbidity responsible for a change in the level of gamma globulin
* Other etiology of granulomatosis

Primary outcomes:
measure: Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity
timeFrame: Day 1
measure: Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT06363682: Interventional Reference Levels (IRL) in Digestive Endoscopy
Official title: Interventional Reference Levels (IRL) in Digestive Endoscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Each Endoscopic Intervention Using X-rays
Keywords: scopy
X rays
digestive endoscopy
interventional reference levels
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 1000
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: All patients who have received an X-ray dose during an endoscopic procedure on one of the 22 private or public hopsitals in France.

Brief summary: Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.

Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.

Secondary objective(s) :

* Application of regulatory texts
* Assessment of patient radiation protection
* Radiation protection assessment for workers

Detailed description: Prospective data collection using an e-CRF available via Easymedstat. Data completed during the endoscopy procedure Completion of a questionnaire by the practitioner who performed the procedure afterwards, including the scopy doses used during the procedure, the type of scopy, the type of intention-to-treat

Eligibility criteria: Inclusion Criteria:

* All patients who have received an X-ray dose during an endoscopic procedure

Exclusion Criteria:

* No X-rays produced
* Medical indication not in favour of the scopy procedure in view of the benefit/risk balance

Primary outcomes:
measure: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.
timeFrame: From enrollment to the end of data collection at 3 months
Secondary outcomes:
measure: Application of regulatory texts
timeFrame: From enrollment to the end of data collection at 3 months
measure: Assessment of patient radiation protection
timeFrame: From enrollment to the end of data collection at 3 months
measure: Radiation protection assessment for workers
timeFrame: From enrollment to the end of data collection at 3 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Hospital University of Nancy
state: Meurthe-et-Moselle
Study officials:
References:
Clinical trial NCT03514082: Oxygen Consumption in Adolescent Idiopathic Scoliosis
Official title: Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who come to our outpatient clinic will be assessed for eligibility.

Brief summary: Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined like decreased torsional movements of spine, increased muscular work and energy expenditure in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions, balance and lower extremity loading symmetry in AIS subjects who are getting conservative treatment.


Eligibility criteria: Inclusion Criteria:

* Cobb angle between 20-45 degree,
* Prescribed a rigid spinal brace by doctor

Exclusion Criteria:

* Having leg length discrepancy more than 1 centimeter
* Having a lung disease
* Having another orthopedic or neurologic disorder

Primary outcomes:
measure: Gait Oxygen Consumption
timeFrame: Assessment will be done at the end of first month of conservative treatment.
Secondary outcomes:
measure: Pulmonary Functions
timeFrame: Assessment will be done at the end of first month of conservative treatment.
measure: Balance
timeFrame: Assessment will be done at the end of first month of conservative treatment.
measure: Lower extremity loading symmetry
timeFrame: Assessment will be done at the end of first month of conservative treatment.
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
state: Famagusta
Study officials:
affiliation: Eastern Mediterranean University
name: Yasin Yurt, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02892682: The Role of the Coagulation Pathways in Recurrent Angioedema
Official title: The Role of the Coagulation Pathways in Recurrent Angioedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.

Detailed description: Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. the main objective is to highlight a difference between the rates of different coagulation factors in the 3 groups presenting different categories of angiodemes patients with a group of patients with isolated superficial chronic urticaria

Eligibility criteria: Inclusion Criteria:

* recurrent angioderma

Exclusion Criteria:

* anticoagulant therapy, diseases of hemostasis

Primary outcomes:
measure: Levels of several coagulation pathway markers in each group
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References:
Clinical trial NCT03443882: Bioavailability of Astaxanthin Formulations
Official title: Bioavailability of Astaxanthin Formulations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Algatechnologies Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.

Detailed description: Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose

Eligibility criteria: Inclusion Criteria:

* Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally, healthy men and women who are 21 to 50 years of age, inclusive, at the baseline visit.

Exclusion Criteria:

* 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.

  2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer or one glass of wine equals one portion of hard liquor).

  7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman

Primary outcomes:
measure: plasma level
timeFrame: 0-48 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Bert W. Strassburger Lipid Center, Sheba Medical Center,
Study officials:
affiliation: Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer
name: Rafael Bitzur, MD
role: PRINCIPAL_INVESTIGATOR
References: