louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01996683: Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
Official title: A Randomized Prospective Comparative Study of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Beta-thalassemia
Serum Ferritin
Iron Chelation Therapy
Keywords: B-thalassemia
ferritin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: safety and efficacy of different iron chelation therapy in transfusion dependent beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.

Detailed description: Treatment of transfusional iron overload in TM patients with low serum ferritin (continued decrease in serum ferritin ) even after reduction of chelation dose.

Eligibility criteria: Inclusion Criteria:

* • Subjects with low transfusional iron overload secondary to thalassemia major showing downward-trend in SF over last 6 months ( 2 readings are needed).

  * Thalassemia major patients with SF equal or less than 500 after reduction of chelation dose. Patients on different types of chelation monotherapy will be included
  * The subjects must also have a level of understanding and willingness to cooperate with the confinement and procedures described in the consent form and scheduled by the study site. In addition, he/she must be able to provide voluntary written informed assent or consent forms.

Exclusion Criteria:

* subjects with HIV positive or have active HCV.
* A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
* Participation in a previous investigational drug study within the 30 days preceding screening.
* A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
* An inability to adhere to the designated procedures and restrictions of this protocol.

Primary outcomes:
measure: downward-trend of SF(serum ferritin) over previous 6 months after reduction of chelation dose with continuation of regular transfusion regimen.
timeFrame: 6 month
Secondary outcomes:
measure: safety and occurrence of AEs in both studied groups (with and without chelation) in relation to different chelation therapy.
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Hematology clinic, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Mohsen S. Elalfy, professour
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00973583: Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections
Official title: Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections; a Randomized Double-blinded Trial in Young Finnish Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: vitamin D
infection
Vitamin D for the prevention of respiratory tract infections
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Finnish Defense Forces
First posted: 2009-09-09
Enrollment: 164
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators earlier clinical study in 754 young Finnish men demonstrated a significant negative association of serum 25-OHD concentration with acute respiratory tract infections. The present study aimed to determine whether vitamin D supplementation may decrease the incidence of acute respiratory tract infections.

Detailed description: Subjects comprised 164 male conscripts at a military base in Finland. Half of the participants were randomly allocated to receive 400 IU vitamin D daily and half received placebo from October through March. Serum vitamin D and plasma parathyroid hormone concentrations were determined. Subjects were followed for 6 months and the primary outcome was the number of days absent from duty due to ARTI.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* Use vitamin D

Primary outcomes:
measure: Number of days absent from duty due to respiratory tract infection
timeFrame: 6 months
Secondary outcomes:
measure: The proportion of men remaining healthy throughout the 6-month study period
timeFrame: 6 months
measure: The number needed to treat calculated from the proportion of men without any days absent from duty
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: university of Tampere
Study officials:
affiliation: Tampere University
name: Ilkka T Laaksi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Department, Centre for Military Medicine, Helsinki, Finland
name: Harri Pihlajamaki, Docent
role: STUDY_DIRECTOR
References:
Clinical trial NCT00427583: Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
Official title: An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Malignant Peripheral Nerve Sheath Tumors
Keywords: Malignant,
peripheral,
nerve sheath tumors,
MPNST,
neurofibromatosis,
NF1,
Imatinib mesylate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors


Eligibility criteria: Inclusion criteria:

* Patients ≥18 years of age
* Histologically documented diagnosis of malignant MPNST
* Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.

Exclusion criteria:

* Patient has received any other investigational agents within 28 days of first day of study drug dosing.
* Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
* Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
* Known CNS metastases

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.
timeFrame: Every 36 weeks
Secondary outcomes:
measure: Time to progression assessed by an MRI scan.
timeFrame: Every 36 weeks
measure: Overall survival
timeFrame: Every 36 weeks
measure: Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs
timeFrame: Every 36 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03751683: Evaluation Genotypic, Phenotypic and Prognosis APECED Syndrome
Official title: Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: APECED
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-11-23
Enrollment: 66
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: A patient diagnosed or suspected of a genetic disorder of immunity control, known as APECED syndrome (Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy) or autoimmune polyendocrinopathy type 1,

Brief summary: The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated


Eligibility criteria: Inclusion Criteria:

* patients with at least 2 major criteria out of the following 3: hypoparathyroidism of autoimmune origin, adrenal insufficiency of autoimmune origin, chronic cutaneous and mucosal candidiasis.
* patients with only 1 of the 3 major criteria, associated with at least 2 of the following minor criteria: hypergonadotropic hypogonadism of autoimmune origin, atrophic gastritis, malabsorption, autoimmune hepatitis, vitiligo, alopecia, chronic keratoconjunctivitis, hypoplasia of dental enamel.
* patients whose molecular diagnosis has been established or who will be established during the inclusion visit with the genetic sample.

Exclusion Criteria:

-

Primary outcomes:
measure: allelic frequency of the mutation c.967-979del13 of the AIRE gene
timeFrame: Baseline: one session
Secondary outcomes:
measure: total number of cases recognized APECED syndrome regardless of the diagnostic criteria used.
timeFrame: Baseline: one session
measure: correlations between the clinical phenotype and the autoantibodies on all cases with APECED syndrome.
timeFrame: Baseline: one session
measure: correlations between the mutations of the AIRE gene and the HLA genotyping on all cases with APECED syndrome.
timeFrame: Baseline: one session
measure: prevalence of types of antibodies found on APECED syndrome.
timeFrame: Baseline: one session
measure: the distribution of lymphocyte subpopulations on the whole cases with APECED syndrome.
timeFrame: Baseline: one session
measure: proportion of patients with a molecular diagnosis of positive APECED syndrome, among patients presenting our new diagnostic criteria (a major criterion and at least 2 criteria
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Emmanuelle Proust-Lemoine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187483: Flash-free Brackets and Dental Plaque
Official title: Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Treatment
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

Detailed description: Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).

Materials \& Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.

Eligibility criteria: Inclusion Criteria:

* being systemically healthy
* having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.

Exclusion Criteria:

-

Primary outcomes:
measure: development of white spot lesion (WSL)
timeFrame: 1 month
Secondary outcomes:
measure: plaque accumulation around the brackets
timeFrame: 1 month
measure: microbial composition around the brackets
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01708083: Polymorphids an mRNA Expression in Obese Genes
Official title: Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymorphism
mRNA Expression
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tree groups; group I: diabetes type II with BMI\>35 Group II: no diabetes BMI\>35 Group III: no diabetes BMI 18-27

Brief summary: Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).

Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese individuals, with or without diabetes typ 2 .

Are there any difference in polymorphids and/or mRNA expression in different types of fat tissue


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery)
* Normal weight without type 2 diabetes BMI 18-25
* Obese without type 2 diabetes BMI\>35
* Obese with type 2 diabetes BMI\>35

Exclusion Criteria:

* under 18 years
* open surgery
* pregnancy
* BMI \>27-\<35

Primary outcomes:
measure: Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity
timeFrame: approximatly 30 minutes after start of operation
measure: Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2
timeFrame: approximatly 30 minutes after start of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta hospital
state: Stockholm County Council
city: Stockholm
country: Sweden
facility: Karolinska Institutet, CMM
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Ass. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941083: Simplification From Protease Inhibitors to Raltegravir
Official title: Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: Simplification from protease inhibitors to raltegravir
Treatment Experienced
HIV-1 Infections
Lead sponsor: Hospital Carlos III, Madrid
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 240
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: A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).


Eligibility criteria: Inclusion Criteria:

* HIV1 sero-positive using standard diagnostic criteria
* Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
* On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry

Exclusion Criteria:

* Pregnancy or breast feeding
* Prior use of Integrase inhibitors
* Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
* UIse of investigational medications within 30 days before study entry or during the trial

Primary outcomes:
measure: Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
timeFrame: 24 weeks
Secondary outcomes:
measure: CD4 gains, lipid profile, adverse events,
timeFrame: 24 weeks
measure: Drug resistance mutations
timeFrame: 24 weeks
measure: Raltegravir through plasma levels and correlation with virological failure
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Carlos III
Study officials:
affiliation: Hospital Carlos III
name: Vicente Soriano, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204. doi: 10.1310/hct1104-197.
Clinical trial NCT05884983: Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma
Official title: Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: Screening
Nasopharyngeal Carcinoma
Dual-energy CT
Endoscopy
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 12000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30-69 years old healthy residences in Zhongshan City

Brief summary: All participants will be tested for EBV-related biomarkers, including EBNA1-IgA, VCA-IgA, and BNLF2b total antibody (P85-Ab), and participants with high serologic risk will be selected based on serologic test results, and dual-energy CT will be performed first for high-risk screening subjects, and dual-energy CT will be performed first for the high-risk group to record dual-energy CT examinations of those suspected of nasopharyngeal carcinoma, and then endoscopy was performed on the high-risk group to record those suspected of nasopharyngeal carcinoma under endoscopy, and finally biopsies were taken for positive lesion sites indicated by dual-energy CT and suspicious lesion sites found by endoscopy to clarify the diagnosis.


Eligibility criteria: Inclusion Criteria:

* Subject residents in Zhongshan City
* Subject has no medical record of nasopharyngeal carcinoma
* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
* Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study

Exclusion Criteria:

* Subject has heavy cardiovascular, liver or kidney disease
* Subject has contraindications to nasopharyngeal endoscopy
* Subject has contrast media allergy

Primary outcomes:
measure: Sensitivity and specificity of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma
timeFrame: 6 months
measure: Positive and negative predictive values of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01802983: The Prognostic Assessment of Extubation in Aged Patients With Multiple Organ Dysfunction Syndrome
Official title: Key Technology Research of the Comprehensive Treatment of Multiple Organ Dysfunction Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Organ Dysfunction Syndrome
Keywords: Aged
Multiple organ failure
Extubation
Prognosis
MODS
invasive mechanical ventilation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between Jan 2009 and May 2013 in the Respiratory Intensive Care Unit(RICU),Surgical Intensive Care Unit(SICU) and Emergency Intensive Care Unit(EICU).

Brief summary: The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to prolongation of intensive and mortality. It is reported that the mortality rates have varied between 20% and 100%, depending on number, severity, duration, type and combination, and definition of dysfunction. In our study, the investigators explore some comprehensive treatment technology to improved outcomes of MODS patients.


Eligibility criteria: Inclusion Criteria:

* age \> 60 years old;
* presence of altered organ function in an acutely ill patient such that homeostasis cannot be maintained without intervention;
* have trachea intubation after admitting to intensive care unit within 24 hours.

Exclusion Criteria:

* end stage multiple organ failure.

Primary outcomes:
measure: the prognostic assessment of aged patients with MODS
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
citation: Xiao K, Su L, Han B, Guo C, Feng L, Jiang Z, Wang H, Lin Y, Jia Y, She D, Xie L. Prognosis and weaning of elderly multiple organ dysfunction syndrome patients with invasive mechanical ventilation. Chin Med J (Engl). 2014;127(1):11-7.
Clinical trial NCT03357783: Macroscopic Deciduosis in Pregnancy is Finally a Common Entity
Official title: Macroscopic Deciduosis in Pregnancy is Finally a Common Entity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deciduitis; Complicating Pregnancy
Keywords: Frequency
Macroscopic
Deciduosis
Ovarian
Neoplasm
Pregnancy
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cesaren section

Brief summary: The purpose of this study is to determine the prevalence of macroscopic deciduosis found randomly in Cesarean sections and the secondary objective to determine the association with any obstetrical complications or adverse effects.

Detailed description: Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and can occur in the cervix, vagina and various abdominal organs like the ovary omentum, appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the kidneys , the lungs and even the skin . Decidualization is a physiologic process during pregnancy, under the influence of ovarian and placental steroid secretion, with total involution in the four to six week post partum period.

Eligibility criteria: Inclusion Criteria:

* All cesarean section

Exclusion Criteria:

* Patients refusing to participate

Primary outcomes:
measure: All cases of cesarean section.
timeFrame: During cesarean section.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital NOVO
name: Georges MARKOU
role: PRINCIPAL_INVESTIGATOR
References: