louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04299750: Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
Official title: Impact of Alveolar Ridge Preservation on Optimal Implant Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Avulsion
Keywords: Socket preservation
Single implant
Tooth extraction
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
name: Geistlich Pharma AG
First posted: 2020-03-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

Detailed description: The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age

  * at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
  * adequate oral hygiene, i.e. plaque index score ≤10%;
  * mesial-distal width of inter-dental space ≥7 mm;

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) score ≥III
* presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
* a history of radiotherapy to the head and neck region
* presence of conditions requiring chronic use of antibiotics
* medical conditions requiring prolonged use of steroids
* history of leucocyte dysfunction
* history of bleeding disorders
* history of renal failure
* patients with metabolic bone disorders
* patients with uncontrolled endocrine disorders
* disability affecting oral hygiene
* alcohol or drug abuse
* HIV infection
* smoking \>10 cigarettes a day or cigar equivalents
* conditions or circumstances that would prevent completion of study participation
* mucosal diseases
* presence of osseous lesions
* severe bruxing or clenching habits
* persistent intraoral infections
* compromised alveolus (dehiscence, etc)

Primary outcomes:
measure: Number of implants ideally placed
timeFrame: 6 months
Secondary outcomes:
measure: Peri-implant bone variation
timeFrame: 6 months
measure: Ridge volume at 6 months after tooth extraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Centro Universitario di Odontoiatria
state: PR
Study officials:
affiliation: University of Parma
name: Guido Macaluso, MDS, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01561950: Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
Official title: Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Haemostasis
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 91
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).


Eligibility criteria: Inclusion Criteria:

* PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
* Platelet count within normal laboratory range

Exclusion Criteria:

* The receipt of any investigational drug within 1 month prior to this trial
* Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin
* (or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial
* African-American race
* Weight above or equal to 160 kg

Primary outcomes:
measure: Bleeding duration measured in minutes
timeFrame: From onset of bleeding till the end of the bleeding
Secondary outcomes:
measure: Blood volume reported in millilitres
timeFrame: From onset of bleeding till the end of the bleeding
measure: Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
timeFrame: Time to onset of clot formation
measure: Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
timeFrame: Time to achieve 20 mm clot strength
measure: Adverse events, including thrombotic events
timeFrame: From screening to day 11-18
measure: Change in coagulation-related parameters after pre-biopsy
timeFrame: From baseline to 15 minutes after pre-biopsy
measure: Change in coagulation-related parameters after biopsy B2
timeFrame: From baseline to 3 hours after B2
measure: Change in coagulation-related parameters after biopsy B3
timeFrame: From baseline to 1 hour after B3
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01026350: Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Influenza
Keywords: modulating immune response to flu antigen
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers ages 18-60
* If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
* Men \> 18 years.
* Ability and willingness of subject to provide informed consent
* Screening tests' results within 15% of normal values

Exclusion Criteria:

* Female
* Continuous use of the following medications for more than 3 days within 30 days of study entry:
* Immunosuppressives
* Immune modulators
* Systemic glucocorticoids
* Anti-neoplastic agents
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
* Subjects with a clinically significant infectious, immune mediated or malignant disease
* Subjects with anemia (Hb \<10.5 gm/dl)
* Subjects with thrombocytopenia (platelets \<100K/µl)
* Subjects with lymphopenia (absolute lymphocyte count \<0.7)
* Subjects who were previously vaccinated against flu.
* Subject who received any vaccination within the last 6 months

Primary outcomes:
measure: alterations in immune response to flu antigen
timeFrame: during and after administration of colostrum enriched with anti flu antibodies
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References:
citation: Kim JH, Jung WS, Choi NJ, Kim DO, Shin DH, Kim YJ. Health-promoting effects of bovine colostrum in Type 2 diabetic patients can reduce blood glucose, cholesterol, triglyceride and ketones. J Nutr Biochem. 2009 Apr;20(4):298-303. doi: 10.1016/j.jnutbio.2008.04.002. Epub 2008 Jul 7.
Clinical trial NCT05325450: Optimization of Hearing Performance in the Subject Implanted
Official title: Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: deafness, cochlear implant
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2022-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two within-subject crossover experiments (short-term and long-term) where each subject will follow two phases of the protocol (training A and training B).
Primary purpose: TREATMENT

Brief summary: In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.


Eligibility criteria: Inclusion Criteria:

* Age\>18
* Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni)
* Person with almost normal or moderate contralateral hearing ( under 60dB)
* Cochlear implanted person whose activation has not yet been performed
* Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant
* Affiliated to social security

Exclusion Criteria:

* - Subjects under juridical protections or tutelage measure
* Subjects with associated neurological or neurodegenerative conditions
* Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant

Primary outcomes:
measure: The primary outcome is the percentage of correct speech recognition after training between the two training programs
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Marx
Study officials:
References:
Clinical trial NCT04489550: How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma
Official title: Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Middle Ear Cholesteatoma
Keywords: residual cholesteatoma
imaging follow-up
canal wall-up tympanoplasty
non-EP DWI
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 17
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: Patients with history of middle-ear cholesteatoma, who underwent canal wall-up tympanoplasty and are therefore at risk of residual cholesteatoma

Brief summary: Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma

Detailed description: A retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 1.5T MRI scanner. MR images were reviewed independently by two radiologists. Sensitivity and specificity values were calculated as a function of time after the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the optimal follow-up duration.

Eligibility criteria: Inclusion criteria:

- patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-EP DWI performed on the same 1.5 Tesla MRI scanner

Exclusion criteria:

- congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first MRI follow-up

Primary outcomes:
measure: MRI sensitivity and specificity values as a function of the duration of the follow-up
timeFrame: 1 day
Secondary outcomes:
measure: Receiver operating characteristics (ROC) curves
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Frederic Venail, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03654950: Patient Empowerment With the Patient Perspective
Official title: PEPP - Patient Empowerment With the Patient Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Högskolan Väst
First posted: 2018-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer

Brief summary: The overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform.

Detailed description: This is a two-stage study design. The first stage consists of focus groups interviews. Three focus groups with 6-8 patients (colorectal cancer patients diagnosed at least one year ago) in each group, will be invited. The focus group interviews will be moderated by one researcher, but accompanied with a second observing researcher. The participants will be identified using the regional Swedish ColoRectal Cancer Registry in Västra Götaland. The participants will be contacted by a short letter (appendix) indicating that we will call them with more information. The participants will by phone be asked to participate in the study and then invited to the focus groups.

The second phase of the project includes a questionnaire, which will be sent to 200 patients from the same population. The questionnaires will be delivered by using the Sunet Survey system, which is a system approved by University of Gothenburg. If the participants prefers a paper copy, or lack the possibility to reply online, a paper copy will be send via mail instead.

At this moment the investigators have developed a questionnaire, which may be refined due to the understating achieved from the focus group interviews.

Eligibility criteria: Inclusion Criteria:

* Patient with colorectal cancer

Exclusion Criteria:

* Inability to give informed consent or speaking and reading the Swedish language.

Primary outcomes:
measure: Patient reported experiences in themes
timeFrame: 1 day
Secondary outcomes:
measure: Patient reported experiences divided into themes
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
affiliation: Sahlgrenska University Hospital and University of Gothenburg
name: Eva Angenete
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00103350: Safety of TG100-115 for Heart Attack Treated With Angioplasty
Official title: A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: myocardial infarction
infarct size
angioplasty
percutaneous coronary intervention
Acute Myocardial Infarction
Lead sponsor: TargeGen
Sponsor class: INDUSTRY
First posted: 2005-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 yrs
* ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4.
* Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.
* Intent to proceed to primary PCI within 6 hours of chest pain onset
* Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.

Exclusion Criteria:

* Female of childbearing potential.
* History of previous myocardial infarction.
* History of congestive heart failure.
* Requirement for a cardiac pacemaker or defibrillator.
* Cardiogenic shock.
* Patients previously treated with thrombolytic therapy.
* Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.

Primary outcomes:
measure: Safety and pharmacokinetics of TG100-115
Secondary outcomes:
measure: Impact of TG100-115 on infarct size
Other outcomes:
Locations:
city: Rochester
country: United States
facility: David Holmes, MD
state: Minnesota
Study officials:
References:
Clinical trial NCT01513850: A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Official title: A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Liver Transplantation
HBV
HBV Recurrence
HBsAg Positive
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Detailed description: A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Eligibility criteria: Inclusion Criteria:

* HBsAg Positive candidate for HBV-related liver transplant
* Primary, single organ recipients
* written informed consent

Exclusion Criteria:

* acute renal failure, Serum creatinin \>1.5\*ULN
* severe cardiac disease or other significant disease
* HAV, HCV or HIV positive
* Immunoglobulin A deficiency.
* History of hypersensitivity to Human Immunoglobulin.
* History of cancer within 5 years. (without HCC)
* History of alcohol or/and drug abuse.
* History organ transplantation.
* Within 30 days, participation in another clinical trial and use of an investigational product.
* Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.

Primary outcomes:
measure: HBV(HBsAg) recurrence
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to recurrence
timeFrame: 52 weeks
measure: Survival
timeFrame: 52 weeks
measure: viral Marker of HBV
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: SKChemicals
state: Gyunggi-do
Study officials:
affiliation: St.Mary's Hospital, Catholic University Medical college
name: Dong Goo Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02895750: Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
Official title: Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Insufficiency, Chronic
Keywords: diabetes type 2
Metformin
chronic kidney disease
CKD
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

Exclusion Criteria:

* Pregnancy and lactation
* Hyperlactatemia (\> 2.5 mmol/L)
* No creatinine levels available since 3 months
* Severe hepatic insufficiency
* No liver function parameters available
* Need of investigation with iodized contrast media
* Hypersensitivity to metformin

Primary outcomes:
measure: Efficacy of once daily Metformin XR on 24-h blood glucose control
timeFrame: week 12
Secondary outcomes:
measure: Tolerability of Metformin XR in mild to moderate (CKD)
timeFrame: week 0, 2, 4, 6, 8, 10 and 12
measure: Tolerability of Metformin XR in mild to moderate (CKD) 2
timeFrame: week 0, 2, 4, 6, 8, 10 and 12
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Jean-Daniel LALAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: