louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00147901: Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
Official title: Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-cell Chronic Lymphocytic Leukemia
Keywords: CLL
Immunochemotherapy
Lead sponsor: German CLL Study Group
Sponsor class: OTHER
Collaborators: name: University of Cologne
name: MedacSchering Onkologie
First posted: 2005-09-07
Enrollment: 61
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 aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.


Eligibility criteria: Inclusion Criteria:

* B-CLL in need of treatment
* One or two prior prior therapies
* WHO performance status 0-2

Exclusion Criteria:

* Serum creatinine \> 1.5 ULN
* Major organ dysfunctions
* Pregnant or nursing

Primary outcomes:
measure: Overall response rate (complete and partial response rate)
timeFrame: 28 days after the end of the last cycle
Secondary outcomes:
measure: Toxicity
timeFrame: 28 days following the last dose of FCCam
measure: MRD response rate
timeFrame: 28 days after the end of the last cycle
measure: Response rate in biological defined risk groups
timeFrame: 28 days after the end of the last cycle
measure: Duration of response
timeFrame: up to 36 months after the end of treatment
measure: Treatment administration (dose intensity)
timeFrame: up to the last day of the last given cycle (day 28 of the 6th cycle)
measure: Overall survival
timeFrame: up to 36 months after the end of treatment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Andreas Engert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elter T, James R, Busch R, Winkler D, Ritgen M, Bottcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Buhler A, Dohner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination with alemtuzumab in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia. Leukemia. 2012 Dec;26(12):2549-52. doi: 10.1038/leu.2012.129. Epub 2012 May 15. No abstract available.
Clinical trial NCT06841601: Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Official title: Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Perception
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients.

This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.


Eligibility criteria: Inclusion Criteria:

1. Patients indicated for simple restorative procedures.
2. Children with physical status ASA I, II.
3. Children with no learning disabilities
4. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
5. Patients whom parents will give consent to participate

Exclusion Criteria:

1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
2. Patients with acute oral or facial infection (swelling and/or cellulites)
3. Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
4. Children with special health care needs.

Primary outcomes:
measure: Pain perception during needle insertion in different anesthetic techniques Using SEM scale
timeFrame: during the procedure (needle insertion)
Secondary outcomes:
measure: Pain will be assessed after local anesthesia injection by means of Visual analogue scale.
timeFrame: immediately after the procedure (needle insertion)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry- Alexandria University
Study officials:
References:
Clinical trial NCT02308501: A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 25
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 Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy


Eligibility criteria: Inclusion Criteria:

* Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
* Have a positive CAC reaction at Visit 1
* Have a positive conjunctival inflammation score at Visit 1

Exclusion Criteria:

* May not use disallowed medications in specified washout period
* May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
* May not have active ocular infection

Primary outcomes:
measure: Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
timeFrame: 1 hour (+30 minutes) post CAC on Day 1
measure: Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
timeFrame: 1 hour (+30 minutes) post CAC on Day 2
Secondary outcomes:
measure: Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
timeFrame: 15 minutes post-study medication instillation
measure: Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
timeFrame: 15 minutes post-study medication instillation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03659201: Efficacy and Safety of Neosil on Chronic Effluvium
Official title: Randomized Clinical Trial, Placebo Controlled and Active Comparator, to Evaluate Efficacy and Safety of Neosil in Chronic Effluvium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Telogen Effluvium
Lead sponsor: EMS
Sponsor class: INDUSTRY
Collaborators: name: Luxbiotech
First posted: 2018-09-06
Enrollment: 232
Sex: FEMALE
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 evaluate the efficacy of Neosil in the treatment of chronic effluvium


Eligibility criteria: Inclusion Criteria:

* Participants who present hair loss for more than 6 months;
* Do not use other possible cosmetic or dermatological treatments, during the trial;
* Not change the diet during the trial and not be any restrictive diet during this period.

Exclusion Criteria:

* Pregnancy or risk of pregnancy and lactating patients;
* Use of any products to promote hair growth within the 6 months prior to the Baseline Visit;
* History of hair transplants;
* Current skin disease;
* History hypersensitivity to the active ingredients used in the study;
* Participation in clinical trial in the year prior to this study;
* Known history of non controled systemic disease (diabetes, hypertension, anemia, iron deficiency, and others);
* Gastric diseases;
* Smoker;
* History of systemic disease (HIV, non specify autoimmune disease, hepatitis, and others).

Primary outcomes:
measure: Hair density
timeFrame: 24 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Caep Centro Avancado de Estudos E Pesquisas Ltda
state: SP
Study officials:
References:
Clinical trial NCT02061501: Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Official title: Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visual Cognitive Deficits
Keywords: visual cognitive deficits
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed.

We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.


Eligibility criteria: Inclusion Criteria:

* visual cognitive deficits
* normal intelligence

Exclusion Criteria:

* cerebral palsy
* mental deficiency
* visual acuity deficit

Primary outcomes:
measure: Calculation of a composite score at Visit 1
timeFrame: Visit 1 (6 months of rehabilitation)
Secondary outcomes:
measure: Calculation of a composite score at Visit 2
timeFrame: Visit 2 (12 months of rehabilitation)
Other outcomes:
measure: Quality of life
timeFrame: Visit 2 (12 months of rehabilitation)
Locations:
city: Strasbourg
country: France
facility: CRTLA - Hôpital de Hautepierre- CHRU Strasbourg
Study officials:
References:
Clinical trial NCT03823001: Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
Official title: Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Magnetic Resonance Imaging (MRI)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.

Detailed description: This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.

Eligibility criteria: Inclusion Criteria:

* Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
* Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
* Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).

Exclusion Criteria:

* Positive DRE;
* PSA \> 10 ng/ml or unstable PSA (doubling time \<3 years) during the last year prior to enrolling in this study;
* PSAD \> 0.15 (calculated using most recent PSA divided by MRI prostate volume);
* First degree relative diagnosed with prostate cancer
* First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
* Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.

Primary outcomes:
measure: Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
timeFrame: Up to 3 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lee Ponsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782001: Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
Official title: Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Malnutrition
Keywords: Vitamin A
Zinc
Malaria
Morbidity
MRDR
Lead sponsor: Kintampo Health Research Centre, Ghana
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
name: University of Wisconsin, Madison
First posted: 2013-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.

Detailed description: The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 - 24 months
* Child's guardian is willing to provide informed consent
* Child's family plans to remain resident in the study areas during the study period

Exclusion Criteria:

* Clinical evidence of vitamin A deficiency
* Severe acute malnutrition
* Severe illness
* Child aged \<6 months or \>24 months
* Receipt of vitamin A supplement within the last three months

Primary outcomes:
measure: incidence of clinical malaria attacks
timeFrame: 6 months
Secondary outcomes:
measure: changes in weight and height/length
timeFrame: baseline and 6 months
measure: changes in vitamin A and zinc nutritional status within and between the groups
timeFrame: baseline and 6 months
measure: change in prevalence of anemia
timeFrame: baseline and 6 months
measure: the incidence of diarrhea and pneumonia
timeFrame: 1 time per week up to 6 months
Other outcomes:
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Centre
state: Brong Ahafo
Study officials:
affiliation: Kintampo Health Research Centre, Ghana
name: Seth Owusu-Agyei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01319201: Subclinical Atherosclerosis Using Dual-source CT Coronary Angiography in Chinese Adults With Different Glycaemic Status
Official title: Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolism
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai

Brief summary: Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status

Aims:

To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)

Study Subjects and Methods:

200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.

Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis

Aims and Methods:

To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up

To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status


Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 70 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria:

1. History of cardiovascular diseases
2. Allergy to iodine
3. Exposure to radiation within last 3 months
4. ALT more than 100IU/L, or serum creatine more than 133μmol/l \[1.5mg/dl\] or GFR less than 60ml/min
5. Heart rate more than 100 bpm or severe arrhythmia
6. Malignancy, myocardial infection, acute hepatitis or other major diseases

Primary outcomes:
measure: Number of participants who will develop cardiovascular events during follow-up
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao-Tong University School of Medicine
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, M.D.; PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082301: Oral Glucose Tolerance Testing After Gestational Diabetes
Official title: Oral Glucose Tolerance Testing After Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Pregnancy
Obesity
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Loyola University
First posted: 2014-03-10
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary cohort is obtained from a pregnant population at two academic medical centers.

Brief summary: This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Gestational diabetes

Exclusion Criteria:

* Multiple gestations
* pre-pregnancy diabetes

Primary outcomes:
measure: Primary outcome: sensitivity of immediate post partum screen
timeFrame: Immediate post partum
Secondary outcomes:
measure: Secondary outcome: physiology
timeFrame: 3 time points: antepatum, immediate postpartum, 6 weeks post partum
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Loyola University
name: Thaddeus Waters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waters TP, Kim SY, Sharma AJ, Schnellinger P, Bobo JK, Woodruff RT, Cubbins LA, Haghiac M, Minium J, Presley L, Wolfe H, Hauguel-de Mouzon S, Adams W, Catalano PM. Longitudinal changes in glucose metabolism in women with gestational diabetes, from late pregnancy to the postpartum period. Diabetologia. 2020 Feb;63(2):385-394. doi: 10.1007/s00125-019-05051-0. Epub 2019 Dec 9.