louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03455361: Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface
Official title: Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Impaction
Keywords: implant stability, dental implants, primary stability
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the sample is composed by patients who had received Stark bone level V-Blast implants in 4 private offices in Italy. The same surgical protocol was used for all implants and a detailed informed consent was obtained from all patients, and included in their respective charts.

For the study objective were enrolled patient who didn't achieved primary stability at the placement: 26 patient

Brief summary: Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.

Detailed description: 26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.

Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.

All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.

Parameter used to assess a low primary stability were:

* insertion torque lower than 10 N / cm
* slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.

Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.

Eligibility criteria: Inclusion Criteria:

* patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
* patient subscribed a detailed informed consent
* same surgical protocol was applied

Exclusion Criteria:

* patient without Stark implant

Primary outcomes:
measure: Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months
timeFrame: 4 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Milan
name: Giulio Rasperini, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02945761: High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
Official title: Ningbo NO.4 Hospital,CHINA.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Infection
Sugar Solution
Lead sponsor: Ningbo Municipal No.4 Hospital
Sponsor class: OTHER_GOV
First posted: 2016-10-26
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgeons easily get wound infections. Most wound infections will be cured by applying medicines and changing dressing in very short period of time. But some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. In order to better change the dressing, it needs to expose the wound thoroughly, which requires to completely open the healed skin, so the healing will be slowed down. Some scholars lay stress on prevention. Wound infection control concerns prevention--not therapy--of an infrequent but expensive kind of surgical morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of topical anti-infectives, which invade the bacteria where they reside, and, consequently, reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a viable treatment option for infections encountered in burns, open wounds, and chronic ulcers. But it is expensive and is difficult to acquire silver-containing dressings. And Recent findings, however, indicate that the compound delays the wound-healing process and that silver may have serious cytotoxic activity on various host cells. (4) As High concentration of sugar solution, honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use of another high-concentration of sugar solution (HCSS) to lavage infected wounds when changing dressings.


Eligibility criteria: Inclusion Criteria:

1. Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions;
2. Except for the incision, primary surgical site has been recovered smoothly. Patients didn't accept secondary operation in the same site;

Exclusion Criteria:

1. Except for the wound that can't use healthy skin closure in Phase I

Primary outcomes:
measure: Duration of wound healing
timeFrame: 4 weeks
measure: The scoring on the open wound
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ningbo NO.4 hospital
name: xinhai weng, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03266861: Lactate Increase in Peripheral Artery Disease
Official title: Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Claudication, Intermittent
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-08-30
Enrollment: 750
Sex: ALL
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: Patient with peripheral artery disease

Brief summary: To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. We use it in routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.

The present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with peripheral artery disease (PAD).

Detailed description: Lactates sample (100 microliter) will be collected at rest Ankle brachial index is measured at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Lactates sample (100 microliter) will be collected at minute 3 of recovery from walking Correlation of lactate increase to the sum of DROP values wil be studied

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Patient able to walk on a treadmill
* Patient covered by the French health insurance
* Patient able to understand the protocol
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* Patient refuses to participate at the this protocol
* Patient has a wash-out period for another clinical trial

Primary outcomes:
measure: Correlation of lactate results to oximetry
timeFrame: one and a half hour
Secondary outcomes:
measure: Correlation of lactate results to resting Ankle to brachial index (ABI)
timeFrame: one and a half hour
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: University Hospitaml in Angers
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382261: Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
Official title: Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of Periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth scaling or quadrant scaling

Detailed description: This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 102 patients, , aged 27 to 65 (mean age 44.2) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility criteria: Inclusion Criteria:

1. good condition of general health,
2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
3. no involvement of the furcation,
4. a minimum of a six teeth per quadrant, respectively.

Exclusion Criteria:

1. periodontal therapy during the last 12 months,
2. assumption of antibiotics during the last 6 months,
3. pregnancy,
4. any systemic condition which might affect the effects of the study treatment,
5. previous or current radiation or immunosuppressive therapies,
6. use of mouthwash containing antimicrobials during the previous 3 months,
7. no use of hormonal contraceptives,
8. medication by anti-inflammatory and immunosuppressive drugs,
9. previous history of hard-drinking,
10. smoking,
11. class II and III tooth mobility.

Primary outcomes:
measure: Clinical Attachment level
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Gaetano Isola
role: STUDY_CHAIR
References:
Clinical trial NCT02076061: Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study
Official title: Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Lung Cancer
Keywords: COPD
Primary Care
Smoking
Smokers
ex-Smokers
Lung Cancer
Cardiovascular Disease
Proteomics
Biomarkers
Biobank
Disease Staging
Gold Stage
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Örestadskliniken
First posted: 2014-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic in Malmö, Sweden

Brief summary: This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.


Eligibility criteria: Inclusion Criteria:

Diagnosed with COPD Gold stage 0-IV

Exclusion Criteria:

Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs

Primary outcomes:
measure: Advanced disease etiology requiring hospitalization.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Örestadskliniken
Study officials:
affiliation: Clincal Chemistry, Lund University
name: Johan Malm
role: STUDY_CHAIR
affiliation: Clinical Protein Science & Imaging, Lund University
name: György Marko-Varga
role: PRINCIPAL_INVESTIGATOR
affiliation: Örestadskliniken Malmö
name: Mikael Truedsson
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Oncology and Pathology, Lund University
name: Elisabet Wieslander
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Protein Science & Imaging, Lund University
name: Thomas E Fehniger
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Protein Science & Imaging, Lund University
name: Magnus Dahlbäck
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Protein Science & Imaging, Lund University
name: Roger Appelqvist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02195661: The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Official title: The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Electroencephalogram
Children
Sedation
Keywords: Epilepsy
Electroencephalogram
children
sedation
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 194
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine the safety and effectiveness of oral melatonin as natural inducer of sleep to acquire useful EEGs in South African children following its introduction as the main agent used in the Neurophysiology department at Red Cross Children's Hospital. This is an observational retrospective study.


Eligibility criteria: Inclusion Criteria:

* All children who were referred to the neurophysiology department who were either unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy "work-up" and whose caregivers agreed to the administering of sedation with melatonin.

Exclusion Criteria:

* Those children undergoing prolonged EEG monitoring (telemetry) or within 24 hours of status epilepticus (prolonged or cluster of seizures).
* Those children are not sedated as natural sleep is always attained with the prolonged monitoring studies, and for those with status epilepticus, there is usually evidence on the EEG of alteration secondary to the effects of status, and the medications administered to control the presenting event.
* Any child deemed to unwell to undergo a non-emergency procedure.
* Any child already receiving anticoagulant medications.
* Any caregiver who deferred sedation for their child was also excluded from the study and in the unit the procedure attempted without sedation.

Primary outcomes:
measure: Efficacy of melatonin to induce sleep for EEG studies
timeFrame: 6 months
Secondary outcomes:
measure: Breakdown data from the successful EEGs -
timeFrame: 6 months
Other outcomes:
measure: Comparison of EEGs performed under melatonin sedation compared to previous unit protocol
timeFrame: 6 months
Locations:
city: Cape Town
country: South Africa
facility: Red Cross War Memorial Children's Hospital
state: Western Cape
Study officials:
References:
citation: Ibekwe R, Jeaven L, Wilmshurst JM. The role of melatonin to attain electroencephalograms in children in a sub-Saharan African setting. Seizure. 2017 Oct;51:87-94. doi: 10.1016/j.seizure.2017.08.002. Epub 2017 Aug 12.
Clinical trial NCT05536661: Impact of Tear Substitute Use on Dry Eye in Gamers.
Official title: Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaporative Dry Eye
Lead sponsor: Laboratorios Thea, Spain
Sponsor class: INDUSTRY
Collaborators: name: Crossdata
First posted: 2022-09-13
Enrollment: 56
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: Clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (Hyabak) versus no intervention.

Detailed description: Adult attendees to a Gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. Participants will be randomized into 2 groups of equal size:

1. Study group.
2. Control group. The Study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days.
* Voluntarily accept to participate and sign informed consent form

Exclusion Criteria:

* Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
* History of ocular trauma or infecction in the last 3 months previous to inclusion.
* History of refractive surgery.
* Visual acuity 0.5 or less in at least 1 eye.
* Ocular medication use in the 3 days prior to inclusion.
* History of systemic condition asociated to dry eye.
* Use of systemic medication known to induce dry eye in the last 30 days.
* Known allergy to hyaluronic acid.
* Pregnant or lactating women.

Primary outcomes:
measure: Standard Patient Evaluation of Eye Dryness (SPEED)
timeFrame: Between Day 1 and Day 3
Secondary outcomes:
measure: Conjunctival hyperemia measured with McMonnies Chapman scale
timeFrame: Between Day 1 and Day 3
measure: Tear Breakup Time (TBUT)
timeFrame: Between Day 1 and Day 3
measure: Conjunctival staining with lisamine green measured with Oxford scale
timeFrame: Between Day 1 and Day 3
measure: Corneal staining with fluorescein measured with Oxford scale
timeFrame: Between Day 1 and Day 3
measure: Schirmer I tear volume test
timeFrame: Between Day 1 and Day 3
measure: Near convergence measured with a RAF binocular gauge
timeFrame: Between Day 1 and Day 3
measure: Accomodation distance measured with a RAF binocular gauge
timeFrame: Between Day 1 and Day 3
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Dreamhack Convention
Study officials:
References:
Clinical trial NCT03314961: Lymph Node Metastases and Arterial Ligation in Rectal Cancer Surgery
Official title: Localisation of Mesenteric Lymph Node Metastases and Role of Level of Arterial Ligation in Rectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Node Metastases
Keywords: rectal cancer
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that were diagnosed with rectal cancer 2012-2016 in Västmanlands county.

Brief summary: Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure.

This study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.

Detailed description: Prospective population-based study of specimens from patients that underwent surgical resection for rectal cancer in Västmanland County, Sweden. Specimens were divided in 3 sections (A-C) and the total amount of lymph nodes and the location of lymph node metastases were analysed.

Multivariate analysis was used to explore the relationship between lymph node counts and age, gender, BMI, preoperative oncological treatment, type of surgery, tumour stage, vessel and specimen length.

Eligibility criteria: Inclusion Criteria:

* All patients that were curatively operated for rectal cancer in Västmanlands county 2012-2016.

Exclusion Criteria:

* Patients that were not operated or had another type of cancer.

Primary outcomes:
measure: Lymph node metastases in rectal cancer
timeFrame: 2012-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Region Västmanland
name: Catarina Tiselius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: