louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00641914: Inhaled Steroid Treatment as Regular Therapy in Early Asthma
Official title: Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Pulmicort
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 6800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 6 and 60 years
* diagnosed with asthma within 2 years of starting the study
* Ability to use a Turbuhaler

Exclusion Criteria:

* Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
* A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
* Regular daily treatment for asthma for more than two years before starting the study

Primary outcomes:
measure: Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)
timeFrame: At week 6 and12, and every 3 months thereafter
Secondary outcomes:
measure: Pre-bronchodilator FEV1 % of predicted normal
timeFrame: At week 6 and12, and every 3 months thereafter
measure: HE: Asthma related events and health care utilisation, and symptom free days (SFD)
timeFrame: At week 6 and12, and every 3 months thereafter
measure: Post-bronchodilator FVC % of predicted
timeFrame: At week 6 and12, and every 3 months thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Steering Committee Chairman
name: Romain Pauwels
role: STUDY_CHAIR
affiliation: Steering Committee Chairman
name: William Busse
role: STUDY_CHAIR
References:
citation: O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31.
Clinical trial NCT00554814: Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency
Official title: Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Latent Iron Deficiency
Keywords: Iron deficiency
Ferritin
Encapsulated iron
Infant formula
Lead sponsor: Bledina
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 249
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.


Eligibility criteria: Inclusion Criteria:

* infant between 6 and 12 months of age,
* preterm infant, low birth weight infant (\< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years),
* infant with a serum ferritin value \< 12ng/ml and with a normal haemoglobin value (\> 11 g/dl), i.e. with a latent iron deficiency,
* infant whose parents or legal tutors have given written informed consent,
* parents or legal tutors agreeing for 4 month follow-up by the investigator,
* infant for which a clinical exam has been performed,
* infant with health insurance.

Exclusion Criteria:

* infant with serum ferritin value \< 12 ng/ml and haemoglobin value \< 11 g/dl
* infant already receiving medicinal iron supplementation,
* infant with acquired or congenital defect,
* infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis)
* infant with congenital and/or chromosomal malformation
* infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters
* infant needing specific infant formula (hypoallergenic, without cow milk proteins)
* infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk

Primary outcomes:
measure: Serum ferritin value measured after 2 months of studied milks consumption.
timeFrame: 2 months
Secondary outcomes:
measure: - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption
timeFrame: baseline, baseline + 2 months, baseline + 4 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Alain BOCQUET
Study officials:
name: Jacques LANGUE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06972914: Effect of Different Wearing Duration of Braces on Short-term Functional Recovery After Anterior Cruciate Ligament Reconstruction
Official title: Effect of Different Wearing Duration of Braces on Short-term Functional Recovery After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Keywords: Anterior cruciate ligament reconstruction
rehabilitation
brace
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after anterior cruciate ligament reconstruction

Brief summary: To evaluate the correlation between wearing time of different braces and short-term functional changes such as knee functional score, knee circumference and postoperative recovery Angle after ACL reconstruction, and provide preliminary evidence and key data for subsequent research on whether and how long it is necessary to wear braces after ACL reconstruction.


Eligibility criteria: Inclusion Criteria:

-Patients with acute anterior cruciate ligament injury undergoing anterior cruciate ligament reconstruction

Exclusion Criteria:

-Refused to sign the informed consent

Primary outcomes:
measure: Thigh circumference
timeFrame: Preoperative, postoperative 3 weeks, 6 weeks, 3 months, 6 months, 9 months
measure: Degree of Joint range of motion
timeFrame: Preoperative, postoperative 3 weeks, 6 weeks, 3 months, 6 months, 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongli
country: China
facility: Peking University Third Hospital of Chongli
state: Hebei
Study officials:
References:
Clinical trial NCT02576314: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
Official title: Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2015-10-15
Enrollment: 48
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 purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.


Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
* HCV RNA \> 10,000 IU/mL at Screening;
* Screening laboratory values within defined thresholds;
* Negative pregnancy test at baseline (females of childbearing potential only);
* Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

* Pregnant or nursing female;
* HIV infection or HBV infection (HBcAb and HBsAg positive);
* Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
timeFrame: Post treatment Week 12
measure: Incidence of adverse events leading to permanent discontinuation of study drug
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
timeFrame: Baseline up to Week 12
measure: HCV RNA levels and change during and after treatment
timeFrame: Baseline up to Week 12
measure: Treatment adherence
timeFrame: Baseline to Week 12
measure: Change in health related quality of life
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04367714: Antibody Response Against SARS-CoV-2 in Dialysis Patients During COVID-19
Official title: Antistof Respons Mod SARS-CoV-2 Hos Dialysepatienter i Forbindelse Med COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Terminal Renal Insufficiency
Keywords: COVID-19
CKD 5
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Central Jutland Regional Hospital
name: Aalborg University Hospital
First posted: 2020-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dilaysis patients on 3 Danish center in Jutland

Brief summary: Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

Detailed description: Blood samples are collected every 14 days

Eligibility criteria: Inclusion Criteria:

* Dialysis

Exclusion Criteria:

* Not willing to give consent

Primary outcomes:
measure: AAntibody response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Godstrup Hospital
Study officials:
References:
Clinical trial NCT01967914: PVI for Prediction of Spinal Induced Hypotension
Official title: Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Induced Hypotension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 38
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: Women undergoing cesarean delivery under spinal anesthesia

Brief summary: The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery


Eligibility criteria: Inclusion Criteria:

* English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
* Scheduled or unscheduled cesarean delivery under spinal anesthesia
* Height: 5 feet-5 feet 11 in.

Exclusion Criteria:

* Laboring women needing an emergency cesarean delivery
* Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
* Severe Cardiac disease in pregnancy with marked functional limitations
* Diabetes type I
* Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
* Inclusion in another anesthetic study involving drug administration.

Primary outcomes:
measure: Correlation between baseline PVI and change in SBP from baseline.
timeFrame: Intraoperative (approximately 2 hours)
Secondary outcomes:
measure: Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors
timeFrame: Intraoperative (approximately 2 hours)
measure: Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.
timeFrame: Intraoperative (approximately 2 hours)
measure: Correlation between baseline PVI and need for vasopressors.
timeFrame: Intraoperative (approximately 2 hours)
measure: Correlation between baseline PVI and change in SBP and PR from baseline.
timeFrame: Intraoperative (approximately 2 hours)
measure: Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors
timeFrame: Intraoperative (approximately 2 hours)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf S Habib, MB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940014: Pulmonary Arteriovenous Malformations (PAVMs) in Hereditary Haemorrhagic Telangiectasia (HHT)
Official title: Pulmonary Arteriovenous Malformations (PAVMs) in Hereditary Haemorrhagic Telangiectasia (HHT): Correlations Between Computed Tomography Findings and Cerebral Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Haemorrhagic Telangiectasia
Pulmonary Arteriovenous Malformation
Cerebral Disorder
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hereditary Haemorrhagic Telangiectasia (HHT) Patients who had a molecular diagnosis and all follow-up clinical assessments available in the database.

Brief summary: Computed tomography (CT) is the modality of choice to characterize pulmonary arteriovenous malformations (PAVMs) in patients with hereditary haemorrhagic telangiectasia (HHT). The objective of this study was to determine if CT findings were associated with frequency of brain abscess and ischaemic stroke.

This retrospective study included patients with HHT-related PAVMs. CT results, PAVM presentation (unique, multiple, disseminated or diffuse), the number of PAVMs and the largest feeding artery size, were correlated to prevalence of ischaemic stroke and brain abscess.


Eligibility criteria: Inclusion Criteria:

* Hereditary Haemorrhagic Telangiectasia (HHT) diagnosis
* Pulmonary Arteriovenous Malformations (PAVMs) related with HHT

Exclusion Criteria:

* Clinical follow-up not available in the database

Primary outcomes:
measure: Yearly change in chest Computed Tomography (CT) results in patients with Hereditary Haemorrhagic Telangiectasia (HHT).
timeFrame: Every year for 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon (Hôpital cardiologique Louis Pradel)
name: Salim Si-Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689714: Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma
Official title: A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Recurrent Endometrial Carcinoma
Keywords: Ovarian Carcinoma
Recurrent Endometrial Carcinoma
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

Detailed description: This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:

* Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
* Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following eligibility requirements to be enrolled in the study.

  1. Subject must be 18 years of age or older.
  2. Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion \> 1.5 cm as diagnosed by ultrasonography, MRI, or CT.
  3. Subject must have good kidney function.
  4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

* Subjects must be excluded if any of the following conditions are present:

  1. Subject is pregnant or breastfeeding.
  2. Subject is simultaneously participating in another investigational drug study.
  3. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
  4. Subject is unable to tolerate conditions for radionuclide imaging.
  5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Val J Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328414: Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
Official title: Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smell Loss
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.


Eligibility criteria: Inclusion Criteria:

* All patients' adults aged from 18 years to 50 will included in the study.
* A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
* suffering from sudden recent anosmia or hyposmia with or without loss of taste.

Exclusion Criteria:

1. Patients with chronic sinusitis.
2. Patients with acute allergic rhinitis.
3. Patients' nasal polyposis
4. Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
5. Patient poly morbidities or poly pharmacy.
6. Elder, pregnant, or nursing woman.
7. Patients with chronic diseases.
8. Autoimmune diseases.
9. Patient suffering end organ problems.

Primary outcomes:
measure: Smell restoring
timeFrame: three week
measure: Smell restoring
timeFrame: three week
Secondary outcomes:
measure: inflammation
timeFrame: three weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
state: المنيا
Study officials:
References:
Clinical trial NCT00509314: The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis
Official title: The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanocyte
Vitiligo
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2007-07-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The aim of this study is to survey melanocytes in the ability of self-assembly on biomaterials and functional analysis in vitro. Also, this study may provide a better way for treatment of vitiligo after understanding the functional aspects of melanocytes.

Detailed description: Vitiligo is a chronic disease that causes loss of melanocyte and pigment of the skin. Traditional treatments for vitiligo including topical corticosteroids and phototherapy lead to limited clinical effects. Autologous melanocyte transplantation is another way to treat vitiligo. However, the effect is largely affected by whether cultivated melanocytes are successfully uptaken by vitiliginous skin. The aim of this study is to survey the self-assembly on biomaterials and functional analysis. In the long run, this study may provide a better way for treatment of vitiligo.

Eligibility criteria: Inclusion Criteria:

* Patients receiving cosmetic removal of moles

Exclusion Criteria:

* No special exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Sung-Jan Lin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin SJ, Jee SH, Hsaio WC, Lee SJ, Young TH. Formation of melanocyte spheroids on the chitosan-coated surface. Biomaterials. 2005 Apr;26(12):1413-22. doi: 10.1016/j.biomaterials.2004.05.002.
citation: Lin SJ, Jee SH, Hsiao WC, Yu HS, Tsai TF, Chen JS, Hsu CJ, Young TH. Enhanced cell survival of melanocyte spheroids in serum starvation condition. Biomaterials. 2006 Mar;27(8):1462-9. doi: 10.1016/j.biomaterials.2005.08.031. Epub 2005 Sep 19.