louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04117932: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Official title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bullous Pemphigoid
Keywords: bullous pemphigoid
ustekinumab
superpotent topical corticosteroids
efficacy
safety
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.

BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.

Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.

Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

Detailed description: The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid

Eligibility criteria: inclusion criteria :

* patient with bullous pemphigoid
* patient aged between 18 and 90
* patient with Karnofsky Performance score \> 60%
* patient agreed to participate to the study

exclusion criteria :

* patient with allergy to corticosteroids
* patient with allergy to ustekinumab
* patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
* malignancy \< 5 years prior to inclusion
* pregnant or nursing (lactating) women, or women of child-bearing potential
* active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion
* history or presence of infection with hepatitis B or C.
* history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Primary outcomes:
measure: complete remission
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT07006532: Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab
Official title: Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Rejection
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 50
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: Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.

Detailed description: The trial is an open-labeled randomized clinical trial that evaluates the safety and efficacy of Tocilizumab as an add-on therapy to standard of care treatment of Plasmapheresis, IVIG, and Rituximab in treatment of CAMR in kidney transplant recipients.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. eGFR\> 25 cc/min
3. Chronicity index \<8
4. IFTA\<40%
5. EBV IgG positive

Exclusion Criteria:

1. Active or recurrent infections
2. History of malignancy, unless in remission for more than 2 years with no relapse
3. abnormal liver function tests
4. Platelet \< 100,000

Primary outcomes:
measure: GFR
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
References:
Clinical trial NCT05523232: Effects of Vibrations on the Biceps Brachii Muscle and Grip Strength
Official title: Effects of Localized Vibration Training on the Biceps Brachii Muscle and Grip Strength in Healthy Adult Males: An Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Keywords: Vibration Training
Biceps Brachii
Muscle Strength
Handgrip
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group parallel design.
Primary purpose: OTHER

Brief summary: It has been suggested that applying acute vibration exercises enhances muscle force, like several weeks of resistance training. The present study investigated the effects of local vibration with two different frequencies on biceps brachii isometric muscle strength and grip strength in healthy young men. Isometric strength of the biceps brachii muscle and grip strength were assessed at baseline and after vibration training (immediate, 10 minutes, and 20 minutes post vibration training).


Eligibility criteria: Inclusion Criteria:

* Healthy adult males

Exclusion Criteria:

* history of recent upper extremity injury
* sensory deficits in the upper extremity
* history of recent upper extremity surgery
* participation in any resistance training

Primary outcomes:
measure: Isometric strength of Biceps brachii muscle
timeFrame: 20 minutes
measure: Hand grip strength
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161432: Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
Official title: Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. Age of 18 to 50 years
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Primary outcomes:
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004
timeFrame: up to 17 days postdose
measure: Cmax (maximum measured concentration of the analyte in plasma) of BI 187004
timeFrame: up to 17 days postdose
Secondary outcomes:
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 17 days postdose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1307.3.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00771732: Using Light Therapy to Treat Toe Nail Fungus
Official title: Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Onychomycosis
Keywords: toe nail fungus
Lead sponsor: Nomir Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To see if four sessions of light therapy successfully treats nail fungus.

Detailed description: This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.

Eligibility criteria: Inclusion Criteria:

* toe nail fungus, not infolving lunula
* between ages 18-70 years old

Exclusion Criteria:

* not on systemic anti-fungal medications

Primary outcomes:
measure: clinical improvement
timeFrame: six months
Secondary outcomes:
measure: mycological negative
timeFrame: 6 months
Other outcomes:
Locations:
city: Southborough
country: United States
facility: Paula Angelini, DPM
state: Massachusetts
Study officials:
affiliation: Nomir Medical Technologies
name: Alan Robbins, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01727232: Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
Official title: Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Thrombocytopenia
Keywords: ITP
Rituximab
Efficacy
Anti-CD20
Regimen
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.

Brief summary: The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .

Detailed description: Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.

Eligibility criteria: Inclusion Criteria:

* Primary ITP
* Age \> 18 years

Exclusion Criteria:

* Secondary ITP
* Age \< 18 years

Primary outcomes:
measure: The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.
timeFrame: one year
Secondary outcomes:
measure: The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.
timeFrame: 3 months, one year, last follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06538532: Anticariogenic Properties of Zamzam Water
Official title: Effect of Zamzam Water on Streptococcus Mutans and Oral pH in High Caries-Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Caries Active
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.

Detailed description: The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.

Eligibility criteria: Inclusion Criteria:

* Male or female participants aged between 18-35 years.
* Systemically- free individuals.
* High caries-risk patients according to ADA (American Dental Association).
* Not on a medication interfering with salivary secretion.
* Co-operative patients approved to participate in the study.

Exclusion Criteria:

* Patients who are already on any mouthwash regime.
* Patients who are on any medication that would alter the salivary secretion.
* Allergy to any of the ingredients of the study products.

Primary outcomes:
measure: Streptomutans count
timeFrame: 3 months and 6 months
measure: Salivary PH level
timeFrame: 3 months and 6 months
measure: caries risk level
timeFrame: 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental medicine for Girls Al Azhar university
Study officials:
References:
Clinical trial NCT00428532: The Effect of Licorice Root Extract and Pomegranate Juice on Atherosclerotic Parameters in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Atherosclerosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will check whether taking 100 mg of licorice root extract or 250 cc of pomegranate juice daily by men with diabetes mellitus who are non-smokers and already treated with statins decreases the risk of developing atherosclerosis. The hypothesis of the study is that natural anti-oxidants (such as licorice root extract and pomegranate juice), by scavenging free radicals, retard and may even reverse atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Male
* Diabetes Mellitus

Exclusion Criteria:

* Younger than 18
* Smoker
* Receiving Fibrates

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek MC
Study officials:
affiliation: Ha'Emek Medical Center
name: Wasseem Rock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03939832: FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass
Official title: Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Planned implementation of deep hypothermic circulatory arrest
* Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.

Primary outcomes:
measure: hospital LOS
timeFrame: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06109532: Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.
Official title: Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyponatremia
Dengue
Inflammation
Keywords: HYPONATREMIA
DENGUE
INFLAMMATION
Lead sponsor: Hospital Nacional Profesor Alejandro Posadas
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 530
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and May 31, 2023.

Brief summary: Prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Detailed description: Background Dengue infection is becoming more prevalent worldwide and is associated with systemic inflammation. Systemic Inflammation is associated with non-osmotic release of ADH.

Methods: Participants conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Eligibility criteria: Inclusion Criteria:

* Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.

Plasma sodium at admission.

Exclusion Criteria:

* None

Primary outcomes:
measure: Admission to the hospital
timeFrame: between january 1, 2023 and november 1, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Haedo
country: Argentina
facility: Ladislao Diaz Ballve
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Posadas
Study officials:
affiliation: HOSPITAL NACIONAL PROF. A. POSADAS
name: CARLOS EGHI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayus JC, Negri AL, Moritz ML, Lee KM, Caputo D, Borda ME, Go AS, Eghi C. Hyponatremia, Inflammation at Admission, and Mortality in Hospitalized COVID-19 Patients: A Prospective Cohort Study. Front Med (Lausanne). 2021 Dec 2;8:748364. doi: 10.3389/fmed.2021.748364. eCollection 2021.