louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04679428: Immunological Characteristics of COVID-19 Patients
Official title: Immunological Characteristics of COVID-19 Patients and Determination of Neutralizing Antibodies Against SARS-CoV-2 Virus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Covid-19
SARS-CoV-2
immunology
TBNK Cells
neutralizing antibodies
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
Collaborators: name: National Institute of Chemistry, Slovenia
First posted: 2020-12-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients recruited at University Clinic of Pulmonary and Allergic Diseases Golnik.

Brief summary: The study will look at the immunological characteristics of COVID-19 patients and determine neutralizing antibodies against SARS-CoV-2 virus.

Detailed description: The immunogram (quantitative TBNK immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by IVD ELISa.

Clinical biochemical and immunochemical (ECLIA) tests (including IL-6) will be performed on Cobas analyzers. Hemogram with differential blood picture will be performed with a hematology analyzer Sysmex XN 3100, examination of blood smears with CellaVision system or. microscope. Coagulation tests will be performed on BCS XP analyzers.

An in-house system for the analysis of SARS-CoV-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. The system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated.

Eligibility criteria: Inclusion Criteria:

Provide written consent before being included in the essay.

Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2).

Exclusion Criteria:

Patients who are unable to give consent or who are unable to follow up will be excluded.

Primary outcomes:
measure: Immunological changes during and after COVID-19 infection
timeFrame: July 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic of Respiratory and Allergic Diseases Golnik
Study officials:
affiliation: Head of the Laboratory for Clinical Immunology and Molecular Genetics
name: Peter Korošec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05148728: Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors
Official title: Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Keywords: active surveillance
fulguration
bladder cancer
Lead sponsor: Vall Hebron Insitut Recerca
Sponsor class: NETWORK
First posted: 2021-12-08
Enrollment: 120
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: Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.

Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.

This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.

This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.


Eligibility criteria: Inclusion Criteria:

* Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
* Accept cystoscopy surveillance
* Main lession less than 10mm
* Less than 7 lesions
* Negative or low grade cytology
* No solid aspect

Exclusion Criteria:

* previous High grade bladder cancer tumors
* previous Cis
* previous Upper Urinary Tract tumor
* previous pelvic radiotherapy
* hematuria
* meatal localisation

Primary outcomes:
measure: Progression rate
timeFrame: two years
measure: Complications rate
timeFrame: two years
Secondary outcomes:
measure: recurrence rate
timeFrame: two years
measure: quality of life measured with CAVICAVENMI questionnaire
timeFrame: two years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fernando Lozano Palacio
Study officials:
References:
Clinical trial NCT05153928: Management of Uterine Leiomyomata and Adenomyosis
Official title: Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Uterine Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2021-12-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: single arm single center study

Brief summary: 1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Detailed description: The aim of the present study is:

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Eligibility criteria: Inclusion Criteria:

- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.

(3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;

Exclusion Criteria:

* (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.

Primary outcomes:
measure: is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Ali
city: Assiut
country: Egypt
facility: Maternaty hospital in assiut
Study officials:
affiliation: Assiut University
name: Hisham Mo Taleb, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilde S, Scott-Barrett S. Radiological appearances of uterine fibroids. Indian J Radiol Imaging. 2009 Jul-Sep;19(3):222-31. doi: 10.4103/0971-3026.54887.
Clinical trial NCT01277328: An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Official title: Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 95
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 rheumatoid arthritis receiving RoActemra/Actemra

Brief summary: This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/=18 years of age
* Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria:

* Hypersensitivity to RoActemra
* Active, severe infections

Primary outcomes:
measure: Mean change in Disease Activity Score 28 (DAS28)
timeFrame: 11 months
Secondary outcomes:
measure: Proportion of patients with a change in Disease Activity Score 28 (DAS28)
timeFrame: 5 months
measure: European League Against Rheumatism (EULAR) response rates
timeFrame: 20 weeks
measure: Proportion of patients with disease remission
timeFrame: 20 weeks
measure: Proportion of patients with low disease activity
timeFrame: 20 weeks
measure: Incidence of adverse events
timeFrame: 11 months
Other outcomes:
Locations:
city: Bucuresti
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01359228: Rifaximin Treatment of Papulopustular Rosacea
Official title: Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.

Detailed description: 100 patients will be randomized into two groups.

Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.

Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.

Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.

Eligibility criteria: Inclusion Criteria:

* Males and females
* \> 18 years of age with rosacea defined as:
* 3-40 papules/pustules and \< 2 nodules,
* A score of 2-4 on the Investigator Global Assessment

Exclusion Criteria:

* Untreated pancreatic insufficiency
* Crohn's disease
* Ulcerative colitis
* Active celiac disease by clinical history
* End stage renal failure
* Less than 18 years old
* Pregnancy or positive pregnancy test
* Rosacea subtype 1 (no papules )
* Topical or oral antibiotics within 4 weeks
* Acne treatments within 4 weeks prior to randomization
* Systemic retinoids within 90 days
* Topical or systemic corticosteroids 4 weeks prior to randomization

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Score of Rosacea Symptoms
timeFrame: 14 days
Secondary outcomes:
measure: Achieving an IGA score of 0.
timeFrame: 14 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF, CTSI, 12-Moffitt/Long Hospital
state: California
Study officials:
affiliation: UCSF, Dept. of Dermatology
name: Martin Steinhoff, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442728: The Effect of Neuromuscular Electrical Stimulation
Official title: on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Coronary Artery Bypass Grafting (CABG)
Chronic Obstructive Pulmonary Disease (COPD)
Ventilatory Failure
Keywords: Functional electrical stimulation
muscular atrophy
intensive care
Lead sponsor: Provinciale Hogeschool Limburg
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2007-03-02
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.

Detailed description: Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap.

Eligibility criteria: Inclusion Criteria:

* . Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.

Exclusion Criteria:

* Patients were excluded from the study if they were still able to move their limb actively in spite of the sedation. Patients were also excluded if they had signs of recent ischemia or infarction for less then seven days. Patients with severe orthopaedic or vascular damage, i.e., fractures or oedema in the lower limbs were also excluded. Patients with an augmented risk for neuro electrical stimulation such as open wounds, hemodialysis or an arterial catheter at the stimulation area were also excluded.

Primary outcomes:
measure: Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: REVAL
state: Limburg
Study officials:
affiliation: PHL
name: RAf LJ Meesen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05491928: Treatment of Metastatic Cancer in Terminally Diagnosed Patients
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Metastatic Cancer
Lead sponsor: Matrix Biomed, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The objective is to provide terminally diagnosed patients with a last line of treatment while improving overall quality of life. Tempol can be added to any chemotherapy regimen to potentially reduce side effects and overcome chemoresistance.

Detailed description: The objective is to provide terminally diagnosed patients assigned to palliative care and palliative chemotherapy a last line treatment with Tempol. In vivo studies have shown Tempol to work synergistically with a number of chemotherapy agents increasing treatment response and reducing chemoresistance. Additionally, Tempol has been shown to provide protection to non-cancerous cells allowing for increased chemotherapy dosing by reducing side effects. Tempol inhibits HIF-1/VEGF among others in cancerous cells while upregulating GSH/NrF2 among others in non-cancerous cells.

Eligibility criteria: Inclusion Criteria:

* metastatic terminally diagnosed cancer

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth University of Colorado Cancer Center - Anschutz Medical Campus
state: Colorado
Study officials:
References:
citation: Ravizza R, Cereda E, Monti E, Gariboldi MB. The piperidine nitroxide Tempol potentiates the cytotoxic effects of temozolomide in human glioblastoma cells. Int J Oncol. 2004 Dec;25(6):1817-22.
Clinical trial NCT06689228: The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Haemodialysis
Keywords: haemodialysis
Orem
Rational Drug use
Nurses
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Orem's Self-Care Deficit Theory and Tele-Monitoring
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with chronic kidney disease may show altered pharmacokinetic and pharmacodynamic response to many drugs compared to patients with normal renal function. Therefore, effective and safe drug use is difficult in patients with chronic kidney disease and especially in dialysis patients. In addition, some drugs may have nephrotoxic effects by causing further deterioration in renal function, especially in high-risk renal patients. Prevention of problems related to drug use in haemodialysis patients will be possible with rational drug use (RUD). RDM is defined as 'the set of rules to be followed in order for patients to take medicines in accordance with their clinical needs, in doses that meet their personal needs, in sufficient time, at the lowest cost to themselves and the society'.

Rational drug use has become an increasingly important concept today. In studies investigating rational drug use, problems such as incorrect use of drugs, prescribing more drugs than necessary, unnecessary injection recommendation/administration, unnecessary antibiotic consumption, and unnecessary use of expensive drugs have been identified. As a result of incorrect drug use, poisoning or decreased sensitivity to drugs are observed.

Detailed description: The Effect of Education Based on Orem's Self-Care Deficit Theory and Tele-Monitoring on Rational Drug Use in Haemodialysis Patients

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* No communication or medically recognised mental problems,
* Patients receiving haemodialysis treatment for 6 months or longer were included in the study.

Exclusion Criteria:

* Diagnosed with psychiatric illness
* Diagnosed with malignancy
* Individuals who do not allow access to their information.

Primary outcomes:
measure: Rationanl Drug use Scale
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
state: Bucak
Study officials:
References:
Clinical trial NCT00793728: Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Official title: Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid obesity
High risk
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.


Eligibility criteria: Inclusion Criteria:

* BMI\>40 kg/m2
* Age \>18 years old
* Eligible for laparoscopic surgery

Exclusion Criteria:

* Prior bariatric surgery
* Sleeve gastrectomy as a part of a duodenal switch
* Second time surgery before 18 months
* Other procedures done during the surgery
* Conversion to laparotomy

Primary outcomes:
measure: Weight lose
timeFrame: One year
measure: Food tolerance
timeFrame: One year
measure: Quality of life
timeFrame: One year
Secondary outcomes:
measure: Metabolic syndrome outcome
timeFrame: One year
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Consultant of Surgery
name: Amador Garcia Ruiz de Gordejuela, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant of Surgery
name: Jordi Pujol Gebelli, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant of Surgery
name: Carles Masdevall Noguera, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611428: Absolute Bioavailability Study With Ipragliflozin
Official title: A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability of Ipragliflozin
Healthy Subjects
Keywords: Ipragliflozin
Healthy
Absolute Bioavailability
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal.
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
* A QTc interval of \>430 ms (males) or \> 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Primary outcomes:
measure: Assessment of the absolute bioavailability after a single oral dose of ipragliflozin
timeFrame: 6 days
Secondary outcomes:
measure: Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin
timeFrame: 6 days
measure: Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
timeFrame: 3 days
measure: Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
timeFrame: 3 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_DIRECTOR
References: