louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03367117: Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematology, Graft, Mobilization
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma or myeloma patients for whom autologous stem cell tansplatation is a therapeutical option

Brief summary: Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® in order to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Detailed description: Autologous cell therapy remains the standard treatment in lymphomas (Hodgkin or non Hodgkin) and myelomas in the first line if they have bad prognostic factors or second-line cases of relapsed or relapsed patients. The essential condition for performing an autograft is the existence of a graft sufficient for this procedure. The European Society of Marrow Transplantation (EBMT) recommends to inject a minimum of 2 × 10 6 CD34 + cells / kg.

Although in terms of conventional products (Neupogen® and Granocyte®), the literature is very rich, there is no data on the use of biosimilars in this indication. A PUBMED search using the terms "peripheral blood stem cell harvest, OR Zarzio® biosimilars" did not produce any results.

Zarzio® has a tolerance and efficacy profile equivalent to "classical" products when used in post-chemotherapy, primary or secondary prophylaxis.

It therefore seems important to compare its efficacy and tolerance in mobilization situations for peripheral stem cell sampling.The Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Eligibility criteria: Inclusion Criteria:

* - Age supérieur to 8 year
* Recommandation of ABSCT

Exclusion Criteria:

* - No indication of ABSCT
* Age inférieur to 18 years

Primary outcomes:
measure: Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF)
timeFrame: Two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06654817: Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris
Official title: Evaluation of Combination Therapy with Ofatumumab and Systemic Corticosteroids for Pemphigus: a Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pemphigus
Pemphigus Vulgaris (PV)
Keywords: Pemphigus
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with alopecia areata

Inclusion Criteria:

Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion Criteria:

* Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

Brief summary: A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.


Eligibility criteria: Inclusion Criteria:

- Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion Criteria:

* Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

Primary outcomes:
measure: Pemphigus Disease Area Index (PDAI）
timeFrame: 36 week
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: Chao Ji
name: Zhuang Zheyu Zheyu Zhuang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05733117: Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease
Official title: Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin D Substitution
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
Collaborators: name: Faculty Hospital Kralovske Vinohrady
First posted: 2023-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

Detailed description: Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.

Eligibility criteria: Inclusion Criteria:

* The inflammatory bowel disease patients

Exclusion Criteria:

* Liver and renal disease
* Hypercalcemia
* Hyperparathyreoidism
* Chronic pancreatitis
* Concomitant vitamin D medication
* Pregnancy
* Sarcoidosis
* Malignancy
* Inability to obtain valid data from subject

Primary outcomes:
measure: Vitamin D (25OHD) blood level
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Zlín
country: Czechia
facility: ThomasBH
Study officials:
affiliation: Tomas Bata Hospital, Czech Republic
name: Vladimír Kojecký, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315417: An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of classic pyoderma gangrenosum
* An active pyoderma gangrenosum ulcer
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
timeFrame: Day 126
Secondary outcomes:
measure: The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
timeFrame: Day 126
Other outcomes:
Locations:
city: Coral Gables
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Ann Arbor
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT06301217: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain
Official title: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Patients With Chronic Nonspecific Neck Pain? - A Cross Sectional Exploratory Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neck Pain
Electromyohgraph
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic nonspecific neck pain lasting longer than three months

Brief summary: Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue.


Eligibility criteria: Inclusion Criteria:

* chronic nonspecific neck pain
* age between 20 and 40 years,
* either sex
* symptoms lasting longer than three months

Exclusion Criteria:

* Pregnancy
* Spinal surgeries
* spinal deformities
* visual or auditory issues
* ongoing physical or medical treatment for cervical or low back pain

Primary outcomes:
measure: Neck disability
timeFrame: at the enrollment
measure: Curvature angle of the cervical spine
timeFrame: at the enrollment
measure: root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula
timeFrame: at the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta university for science and technology
state: Dakahleya
Study officials:
References:
Clinical trial NCT00438217: Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
Official title: Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Central Precocious Puberty
Keywords: precocious puberty, genetics, environmental factors
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. In this view, we are collecting clinical data and biological samples of children attended as outpatients at the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different GnRH agonists.


Eligibility criteria: Inclusion Criteria:

* Clinica diagnosis of central precocious puberty
* Diagnosis is based on growth spurt, bone age advancement, positive GnRH agonist stimulating test, pubertal sex steroid levels before 8 years of age for female and 9 years for male, respectively

Exclusion Criteria:

* Thyroid disorders
* Peripheric diagnosis of precocious puberty
* Genetic disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa
Study officials:
affiliation: Department of Pediatrics, University of Pisa
name: Giuseppe Saggese, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04383717: Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
Official title: The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Respiratory Tract Infections
Keywords: Levamisole
Isoprinosine
COVID19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of both levamisole \& Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection

Detailed description: Study design: Randomized controlled trial, randomization by closed envelope technique Informed consent will be written for each patient of either group

At the beginning of the study all patients will have the following investigations done: CBC with differential, ESR, PCR for COVID 19, D dimer and CT chest and confirmed cases will included in the study

Pregnant and lactating women together with children with other comorbidities will be excluded from the study

Study groups:

Duration of the study is 4 weeks

Both groups with persistent COVID 19 symptoms that require hospitalization

Group 1: 30 patients with confirmed COVID19 infection and sharing clinical features like fever, malaise, sore throat, runny nose, persistent cough \&dyspnea, requiring hospitalization

Group 2: control group: 30 patients

Treatment endpoint • Cure of patients: Improvement of symptoms Laboratory findings ESR and total leucocytic count returning to normal PCR negative Radiological improvement

• Worsening of symptoms or fatalities

Eligibility criteria: Inclusion Criteria:

* Confirmed COVID 19 infection (positive PCR, elevated ESR, leucopenia)
* Clinical picture of COVID 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose

Exclusion Criteria:

* Mild cases of COVID 19 that do not require hospitalization
* Pregnant \& lactating women
* Children with other comorbidities
* People who received previous treatment for COVID 19 in the last 2 weeks N.B. Diabetes and hypertension not excluded

Primary outcomes:
measure: COVID 19 induced fever in both groups
timeFrame: 4 weeks
measure: COVID 19 induced dyspnea in both groups
timeFrame: 4 weeks
measure: COVID 19 viral load in both groups
timeFrame: 4 weeks
Secondary outcomes:
measure: laboratory clearance in both groups: CRP in mg/dL
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mohamed El Darouti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227317: BIOmarkers of Dyspnea IN Emergency Room
Official title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Dyspnea
CAPD
AE COPD
Acute Heart Failure
Pulmonary Embolism
Keywords: Dyspnea
Mortality
Lead sponsor: ThermoFisher Scientific Brahms Biomarkers France
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe acute SOB Suspicion of CAP, Acute Heart failure, AE COPD or PE

Brief summary: The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.

Detailed description: In emergency department shortness of breath (SOB)is a common symptom and its cause is not easy to be identified. The risk stratifying remains a challenge, Prognostic value of biomarkers might be helpful.

Eligibility criteria: Inclusion Criteria:

* tachypnea \> 25 /min or Pa02 \< 70 mmHg or SpO2 \< 93%
* diagnosis suspected: CAP, PE,EACOPD, AHF

Exclusion Criteria:

* other cause of dyspnea,
* unreachable on Day 30

Primary outcomes:
measure: prognostic value of PCT, MR proADM, Mr pro ANP, Copeptin and pro endothelin in SOB
timeFrame: at Day 30
Secondary outcomes:
measure: establish the diagnostic value of PCT and MR pro ANP
timeFrame: at admission
Other outcomes:
Locations:
city: Paris
country: France
facility: Emergency department of Pitié Salpetriere Hospital
Study officials:
affiliation: ED Pitié SalpêtrièreHospital in Paris
name: Pierre Hausfater, Pr
role: STUDY_CHAIR
affiliation: ED Cochin Hospital in Paris
name: Yann-Erick Claessens, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: ED Hotel Dieu Hospital in Paris
name: Guillaume Der Sahakian, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: ED Hotel Dieu Hospital in Nantes
name: Arnaud Martinage, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: ED La Miletrie Hospital in Poitiers
name: Fatima Rayeh, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: ED Hospital B in Lille
name: Eric Weil, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: ED Charles Nicolle Hospital in Rouen
name: Luc-Marie JOLY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01158417: Resveratrol in Type2 Diabetes and Obesity
Official title: Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Insulin Resistance
Keywords: Type 2 Diabetes
Obesity
Insulin Resistance
Resveratrol
Inflammation
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Kaleida Health
First posted: 2010-07-08
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.

Detailed description: The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.

Eligibility criteria: Inclusion Criteria:

1. 20 years of age and older
2. Healthy Obese subjects with BMI \> 30
3. Type 2 Diabetics with BMI \> 30
4. Subjects with good peripheral vein.
5. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.

Exclusion Criteria:

1. Subjects on any antioxidant medication
2. Patient on non-steroidal anti-inflammatory drug
3. On any agent with significant antioxidant properties.
4. History of drug or alcohol abuse
5. Any life threatening disease
6. Allergy to peanuts, grapes, wine, mulberries.
7. Pregnant women.
8. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
9. Subjects on anticoagulants.

Primary outcomes:
measure: NF-Kb
timeFrame: 12 weeks
Secondary outcomes:
measure: GLP-1
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Williamsville
country: United States
facility: Jeanne Hejna
state: New York
Study officials:
affiliation: Kaleida Health
name: Paresh Dandona, MD
role: PRINCIPAL_INVESTIGATOR
References: