louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01105026: A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
Official title: Bone Regeneration by Means of a Bioactive Glass Scaffold.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alveolar Bone Loss
Keywords: alveolar ridge preservation, bioactive glass, tooth extraction, graft material
Lead sponsor: University of Trieste
Sponsor class: OTHER
Collaborators: name: Inion Oy
First posted: 2010-04-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.

Detailed description: 14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy females or males subjects.
* They did not smoke
* Did not take any medications.

Exclusion Criteria:

* Subjects with less than 18 years of age,
* with current alcohol or drug abuse,
* with systemic/local conditions that would interfere with wound healing or osseointegration
* with a history of chemotherapy and radiotherapy in the head and neck region.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clozza E, Biasotto M, Cavalli F, Moimas L, Di Lenarda R. Three-dimensional evaluation of bone changes following ridge preservation procedures. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):770-5.
citation: Clozza E, Pea M, Cavalli F, Moimas L, Di Lenarda R, Biasotto M. Healing of fresh extraction sockets filled with bioactive glass particles: histological findings in humans. Clin Implant Dent Relat Res. 2014 Feb;16(1):145-53. doi: 10.1111/j.1708-8208.2012.00463.x. Epub 2012 Jun 12.
Clinical trial NCT01361165: Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Official title: Data Analysis for 04-C-0234 Tenofovir Disoproxil Fumarate Salvage Therapy in HIV-Infected Children and a Study of Its Effect on Bone Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-Infected Children
Keywords: Pediatric
Data Analysis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-05-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

Detailed description: We plan to analyze the data to meet the primary objective of the study:

To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA, during and following treatment with tenofovir DF-containing antiretroviral therapy in HIV-infected children.

In addition, we plan to analyze the data to meet 2 secondary objectives of the study:

1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir DF-containing antiretroviral therapy.
2. To study immunologic, virologic and clinical effects of tenofovir DF administered to HIV-infected children in combination with other antiretroviral therapies.

Eligibility criteria: * Data Analysis Only

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
Clinical trial NCT01809366: Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect on Implantation and Pregnancy Rates
Keywords: seminal plasma/uterine receptivity
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.


Eligibility criteria: Inclusion Criteria:

* patients undergoing oocyte pick up for IVF treatment

Exclusion Criteria:

* endometriosis
* low responders
* uterine malformations

Primary outcomes:
measure: implantation rate
timeFrame: 4 weeks after ET
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks after ET
measure: ongoing pregnancy rate
timeFrame: 6 weeks after ET
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Infertility and IVF Unit, Assaf harofeh Medical Center
Study officials:
References:
Clinical trial NCT00157066: Effects of Vitamin D Supplementation on Antimycobacterial Immunity
Official title: Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Latent tuberculosis infection
Active tuberculosis infection
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: University of Cape Town
name: Newham Chest Clinic, London E7 8QP, UK
name: Northwick Park Hospital, Harrow, UK
name: Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK
name: Environmental Health Department, London Borough of Newham, London E15 4SF, UK
name: Wellcome Trust
First posted: 2005-09-12
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.


Eligibility criteria: Inclusion Criteria:

* Adult
* Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Hyperparathyroidism
* Sarcoidosis
* Renal failure
* HIV infection

Primary outcomes:
measure: Bacillus Calmette-Guerin (BCG) lux whole blood assay
Secondary outcomes:
measure: Antigen-stimulated whole blood interferon gamma production
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tuberculosis Clinic, Newham Chest Clinic
Study officials:
affiliation: Centre for Health Sciences, Barts and The London, QMUL
name: Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, Hall BM, Packe GE, Davidson RN, Eldridge SM, Maunsell ZJ, Rainbow SJ, Berry JL, Griffiths CJ. A single dose of vitamin D enhances immunity to mycobacteria. Am J Respir Crit Care Med. 2007 Jul 15;176(2):208-13. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.
Clinical trial NCT00367666: Using Diagnostic Tools to Stage Breast Cancer
Official title: Evaluation of Multimodality Breast Imaging: Lesion Staging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2006-08-23
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project is aimed at investigating the relative diagnostic and synergy of four state of the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to determining the extent of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Women recently diagnosed with Breast Cancer
* Will be undergoing surgery (after study) at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Contraindications to MRI
* previously diagnosed with breast cancer (in the smae breast) within the past 5 years
* Patients with known locally advanced cancer (prior to study entry) being treated with preoperative adjuvant therapy.
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Abass Alavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03075566: Coronary Artery Disease: a Case- Control Study
Official title: Clinical and Biochemical Markers in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
risk factors
inflammation
biomarkers
atherosclerosis
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 517
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 310 patients with Coronary Artery Disease
* 207 healthy subjects

Brief summary: Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement of several pathological events, and alteration in the serum levels of pro- and anti-inflammatory, and lipid markers.

The investigators evaluated the contribution of serum biomarkers levels to the pathogenesis of coronary artery disease, namely their association with risk factors, clinical presentation, extent and severity of atherosclerotic changes accompanying coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Coronary Artery Disease

Exclusion Criteria:

* Severe respiratory disease
* Liver disease
* kidney disease
* Inflammatory diseases (infections, autoimmune disorders, malignancy).

Primary outcomes:
measure: Biochemical parameters
timeFrame: 1 Days
measure: Inflammatory markers
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Faculty of Pharmacy
state: Ibn Sina Street
Study officials:
affiliation: University of Monastir, Faculty of Pharmacy of Monastir, Tunisia
name: Salima Ferchichi, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01814566: Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Official title: Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Angina Pectoris
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 30000
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: An anticipated sample size was caculated in this study, about 30000 Patients using DanshenDuofensuanyan injection from 2013 to 2014 in more than 20 hospitals

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015.

Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants with adverse events; incidence of DanshenDuofensuanyan'adverse drug reaction（ADRs）and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: to assess DanshenDuofensuanyan's 'adverse event' and 'drug adverse reaction' during patients' hospital stay. The registry procedure will last 2 years only for patients using DanshenDuofensuanyan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05476666: Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial
Official title: Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripherial Venous Pressure
Central Venous Pressure
Fluid/Volume Status Monitoring of Patient
Keywords: Peripherial venous pressure
Central venous pressure
Lead sponsor: Pakistan Navy Station Shifa Hospital
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is aimed at comparing peripherial venous pressure as an indicator of central venous pressure in post operative surgical patients.


Eligibility criteria: Inclusion Criteria:

* ASA I/II/III surgical patients who require central venous access as part of their surgical treatment plan with no organ support in post operative period.
* Age between 18 and 75 years
* Who have atleast 1 x 18 gauge peripherial venous cannula in the upper limb from elbow below to the hand
* Who have given consent

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Peripherial venous pressure as an indicator of central venous pressure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: PNS Shifa Hospital
state: Sind
Study officials:
affiliation: Pakistan Navy Station Shifa Hospital
name: Kenan Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05236166: Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
Official title: Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy in 2-year Seizure-free Adult Patients With Epilepsy (RASLOW) Study: a Pragmatic Multicentre, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2022-02-11
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.


Eligibility criteria: Inclusion Criteria:

* diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria)
* age at epilepsy onset of 16 years or older
* seizure freedom for at least 2 years
* treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide)
* adherence to the protocol and visit schedules.

Exclusion Criteria:

* inability to understand the aims or modalities of the study;
* current pregnancy or plans to become pregnant during withdrawal period;
* history of seizure relapse after discontinuation of treatment;
* history of psychogenic non-epileptic seizures (PNES);
* history of status epilepticus

Primary outcomes:
measure: Time to seizure relapse
timeFrame: 365 days
Secondary outcomes:
measure: Patients' compliance with the assigned withdrawal schedule
timeFrame: 365 days
measure: Severity of relapses and mortality
timeFrame: 365 days
Other outcomes:
Locations:
city: Reggio Calabria
country: Italy
facility: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro
Study officials:
References:
citation: Del Felice A, Beghi E, Boero G, La Neve A, Bogliun G, De Palo A, Specchio LM. Early versus late remission in a cohort of patients with newly diagnosed epilepsy. Epilepsia. 2010 Jan;51(1):37-42. doi: 10.1111/j.1528-1167.2009.02141.x. Epub 2009 Jun 1.
citation: Ranganathan LN, Ramaratnam S. Rapid versus slow withdrawal of antiepileptic drugs. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005003. doi: 10.1002/14651858.CD005003.pub2.
Clinical trial NCT04591366: Barrier-Protect Study
Official title: Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infection
Keywords: Cardiac
Device
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the implant procedure can be one of the potential improvements to prevent CIED infections. Patients requiring a lead change, battery change or device upgrade will be eligible. This is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). Patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.


Eligibility criteria: Inclusion Criteria:

1. Patient aged 18
2. Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket.
3. PADIT risk score ≥ 5

Exclusion Criteria:

1. Unable or unwilling to provide informed consent.
2. De novo device implantation.
3. Active device infection.
4. Iodine allergy
5. Life expectancy less than 2 years

Primary outcomes:
measure: End of surgery pocket swab culture positivity
timeFrame: one month post procedure
Secondary outcomes:
measure: CIED infection, defined as in the recent PADIT trial
timeFrame: Year 1 and 2 post procedure
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Alper Aydin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03511066: A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection
Official title: A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Influenza A
Keywords: efficacy
safety
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 228
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Detailed description: This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Eligibility criteria: Inclusion Criteria:

* Male or Female subjects between the ages of 19 and 64 years, both inclusive
* Diagnosed with influenza A at screening using rapid influenza diagnostic test
* Onset of influenza symptoms and fever is within 48 hours at screening
* At least 2 of symptoms (moderate to severe in intensity)
* ≥38.0'C body temperature at screening

Exclusion Criteria:

* Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
* Positive influenza B or A+B infection

Primary outcomes:
measure: Time to Resolution of Influenza Symptoms and Fever
timeFrame: Twice a day (Morning and Evening) from Day 1 to Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Celltrion Inc.
name: MoonSun Choi
role: STUDY_DIRECTOR
References: