louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01657513: TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
Official title: Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
treatment failure
tnf-alfa
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: The Michaelsen Foundation
name: Pfizer
First posted: 2012-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects.

Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration.

The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age above 18
* Psoriasis
* Indication for treatment with tnf alfa blocking drug
* Written informed consent obtained

Exclusion Criteria:

* Severe psychiatric disorder
* No indication for treatment with tnf-alfa blocking drug
* Pregnancy
* Breastfeeding
* No written informed consent

Primary outcomes:
measure: change in concentration of tnf-alfa antibodies in serum
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
Secondary outcomes:
measure: change in severity of psoriasis, PASI
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
measure: Presence of psoriatic arthritis
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
measure: change in dermatology life quality index (DLQI)
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
measure: height (cm)
timeFrame: 3 months
measure: change in weight (kg)
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
Other outcomes:
measure: assessment of change in concentrations of other biomarkers of interest in psoriasis
timeFrame: 3, 6, and 12 months after start of tnf-alfa blocking agent
Locations:
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital Gentofte, Department of Skin and Allergies
city: Stockholm
country: Sweden
facility: Karolinska Institute, Department of Medicine
Study officials:
affiliation: Copenhagen University Hospital Gentofte, Department of Skin and Allergies
name: Lone Skov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institute, Department of Medicine
name: Mona Ståhle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04074213: Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Official title: Clozapine and Haematologic Malignancies: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Leukemia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with at least one liable antipsychotic drug (ATC class N05A)

Brief summary: Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed description: Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019
* Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)
* Patients treated with at least one liable antipsychotic drug (ATC class N05A)

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
Secondary outcomes:
measure: investigate a potential dose-dependent effect
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
measure: Description of the clinical features of clozapine-related haematologic malignancies
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital, Department of Pharmacology
state: Normandie
Study officials:
affiliation: University Hospital, Caen
name: Basile Chrétien, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343213: Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
Official title: Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Keywords: Prognostic value of p16INK4a
CIN 1
LSIL
HPV
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-06-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.


Eligibility criteria: Responsible women \> 18 years with histologically proven CIN 1

Primary outcomes:
measure: p16INK4a staining pattern and HPV status of the initial biopsy
Secondary outcomes:
measure: p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
Other outcomes:
Locations:
city: Haguenau
country: France
facility: Service de Gynécologie-Obstétrique - Centre Hospitalier Général
city: Saverne
country: France
facility: Service de gynécologie-obtétrique - Centre Hospitalier Général
city: Strasbourg
country: France
facility: Département de Gynécologie-Obstétrique - Hôpital de Hautepierre
Study officials:
affiliation: Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
name: Jean-Jacques Baldauf, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04690413: NOWDx Test for the Detection of Antibodies to COVID-19
Official title: NOWDx Test for the Detection of Antibodies to COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV-2
Coronavirus
Lead sponsor: NOWDiagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).

Detailed description: This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).

The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing of human venous whole blood (EDTA) and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests.

Eligibility criteria: Inclusion Criteria:

* Persons ≥18 years old;
* Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report.

Exclusion Criteria:

* Persons \<18 years old;
* Persons who have previously participated in a NOWDx study.

Primary outcomes:
measure: Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research, LLC
state: Florida
city: Jackson
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
Study officials:
affiliation: NOWDiagnostics, Inc.
name: Beth L Cobb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750813: ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
Official title: ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 252
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 compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.


Eligibility criteria: Inclusion Criteria:

* Must sign informed consent form;
* Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
* Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
* Cylinder equal or lower than -0.75D in both eyes;
* Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
* Can be successfully fitted with both study lenses at Visit 1;
* Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Fitted with monovision;
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Current DT1 or AO1D lens wearer;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
timeFrame: Day 14, each product
Secondary outcomes:
measure: Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
timeFrame: Day 14, each product
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, A Novartis Division
name: Sr. Clinical Manager, Global Medical Affairs, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00796913: Remission Induction and Sustenance in Graves' Disease 2
Official title: Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graves Disease
Hyperthyroidism
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.

Detailed description: A detailed description of patients entering the initial observational phase of the study (RISG1) has been published:

Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487.

Eligibility criteria: Inclusion Criteria:

* Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

* Age \< 18, severe concomitant disease

Primary outcomes:
measure: Relapse of hyperthyroidism
timeFrame: 2 years
Secondary outcomes:
measure: Reoccurrence of TSH-receptor autoimmunity
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Jesper S Karmisholt, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karmisholt J, Andersen SL, Bulow-Pedersen I, Carle A, Krejbjerg A, Nygaard B. Predictors of Initial and Sustained Remission in Patients Treated with Antithyroid Drugs for Graves' Hyperthyroidism: The RISG Study. J Thyroid Res. 2019 Jan 3;2019:5945178. doi: 10.1155/2019/5945178. eCollection 2019.
Clinical trial NCT00004313: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Addison's Disease
Keywords: Addison's disease
endocrine disorders
rare disease
primary adrenal insufficiency
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, Los Angeles
First posted: 1999-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by age.

Patients are randomly assigned to androgen replacement therapy with daily dehydroepiandrosterone (DHEA) or placebo for 6 months. All patients may receive 6 additional months of DHEA following randomized therapy.

Women on hormonal replacement therapy may receive concurrent conjugated estrogens or oral medroxyprogesterone.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Primary adrenal insufficiency (Addison's disease) Serum dehydroepiandrosterone less than 0.5 nmol/L --Prior/Concurrent Therapy-- No concurrent investigational drug Stable glucocorticoid/mineralocorticoid dose over past year required --Patient Characteristics-- Hepatic: No hepatic disease Cardiovascular: No vascular disease No thrombotic disorder No angina No elevated blood pressure on 2 readings taken 15 minutes apart in 1 visit, i.e.: Systolic greater than 165 mm Hg OR Diastolic greater than 95 mm Hg Other: No clinically significant medical abnormality No gallbladder disease No malignancy No estrogen- or androgen-dependent neoplasia Benign prostatic hyperplasia eligible No other endocrine disease Controlled thyroid disease with normal thyroid-stimulating hormone eligible Mammogram required within 1 year prior to entry for women aged 40 and over No clinically significant abnormality No undiagnosed vaginal or uterine bleeding within 6 months prior to entry Pap smear required within 1 year prior to entry No dysplasia (squamous intraepithelial lesion low-grade or higher)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Samuel S. C. Yen
role: STUDY_CHAIR
References:
Clinical trial NCT06996613: Liberal Versus Restrictive Transfusion Strategy in Patients With Upper Git Bleeding
Official title: Liberal Versus Restrictive Transfusion Strategy in Patients With Upper Git Bleeding in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Upper Git Bleeding
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with upper Git bleeding in sohag university hospital

Brief summary: Comparison between the effects and results of the two strategies of blood transfusion, liberal and restrictive in patients with upper Git bleeding

Detailed description: Comparison between safety, efficacy and mortality rate in the two strategies of blood transfusion, liberal(target Hb 9-11g/dl) and restrictive(target Hb 7-9 g/dl )in patients with upper Git bleeding in sohag university hospital, and how other risk factors as liver cirrhosis , CKD,and cause of bleeding in the patient affect results and expected complications that may be occur after blood transfusion

Eligibility criteria: Inclusion Criteria:

* all patients presented by upper GIT bleeding and their CBC show anemia and need blood transfusion

Exclusion Criteria:

* all patients less than 18 years and patients have anemia and received blood transfusion by another causes other than GIT bleeding

Primary outcomes:
measure: the rate of complication of both liberal and restrictive transfusion strategy in upper Git bleeding
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine sohag university
Study officials:
affiliation: Sohg university hospital
name: Reham Elsayed
role: STUDY_CHAIR
affiliation: Tertiary hospital
name: Reham Elsayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978613: Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects
Official title: Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
* Age 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI): 20.0-29.9 kg/m\^2 (both inclusive)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
* Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted

Primary outcomes:
measure: Number of treatment emergent adverse events recorded
timeFrame: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
Secondary outcomes:
measure: Number of hypoglycaemic episodes
timeFrame: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
measure: Area under the NNC0113-0987 plasma concentration time curve
timeFrame: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
measure: Maximum observed NNC0113-0987 plasma concentration
timeFrame: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: